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Validation Lead: Qualification - Pharmaceutical
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General Details
Description
Qualifications Required:
- Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent.
Necessary Experience and Industry Accreditation
- At least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.
- At least 1 to 2 years’ experience at junior to Senior Management level.
- Experience in quality management systems within a cGMP facility.
- Good Engineering Practice and understanding of ISPE guide.
Key Duties and Responsibilities
- Management and mentorship of Senior Validation Scientists, Validation Scientists and Validation Interns.
- Ensuring that Validation requirements are achieved at the required quality and regulatory levels (Company, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.
- Conduct section planning and execute activities within own scope of accountability.
- Ensure adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
- Role profiling, goal setting and performance management of Validation staff within the section.
- Review and/or update high level validation and qualification guidance documents, such as VMP, VPs, SOPs.
- Attend and participate on technical and projects strategic meetings/discussions involving internal and external stakeholders.
- Ensure execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.
- Review and approves protocols and reports for all qualification activities based on company standards/guidelines, procedures, and
- Industry current practices.
- Reporting on key operations, critical numbers and key performance indicators that impacts the section’s short, medium- and long-term objectives.
- Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
- Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
- Assist in Process Development activities including Process Validation, Cleaning Validation and Cold Chain.
- Participate in Process Automation and Data Management activities including Data Integrity and CSV.
- Ensure execution of qualification processes: FAT, Commissioning, SAT, DQ, CIA, SLIA, IQ, OQ, PQ and PRQ as per defined timelines and cGMP and report timeously on qualification progress and status to the Validation Manager.
- Ensure and or assist system/ equipment owners with identifying maintenance and calibration requirements.
- Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed.
- ...
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Id Subtitle 1120951651
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ABC Worldwide
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Department : Operations: Processing Centre
Reports To : Processing Centre Manager
Job Grade : C3
Location : Cape Town
Contract : This position is project based for 6 months and may be extended in line with project requirements.
ROLE PURPOSE
To ensure that all projects undertaken are completed within time and quality requirements.
KEY RESPONSIBILITIES include the following. Other duties may be assigned.
Process Management
Gains an understanding of project requirements, i.e. time and resources.Ensure work is delivered to Metrofile within the requirements.Ensure a continuous flow of work from the project.Meet with customer departments to secure the work.Assists with site and resource establishment for the project.Monitors daily project performance against production schedule.Reports project status and projections to the client and Processing Centre Manager on a daily and weekly basis as required.Facilitates and ensures optimal resolution of processing and/or resourcing issues and escalates to the Processing Centre Manager when necessary.Ensures project output objectives are timeously met as required.Ensures that all elements of the project are completed and finalised.Assist with any processing requirements within the department to ensure the department is run efficiently and effectively.Support the processing manager in all functions.
MINIMUM QUALIFICATIONS, EXPERIENCE and KNOWLEDGE:
The requirements listed below are representative of the knowledge, skill, and/or ability required.
B Degree / Project Management Diploma or equivalent qualificationMinimum 3 years project management experienceMust have a valid code 08 drivers licenceMust have a clear criminal recordExcellent command of the English languageMust have excellent communication and interpersonal skillsMust be customer focusedMust pay attention to detailMust be a team playerMust be able to work independently and adhere to deadlines and strict turnaround timesMust have business acumen and be able to communicate at all levelsMust be professional at all timesMust be highly computer literateDemonstrate excellent organisational and problem solving skills
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We are looking to recruit a permanent Responsible Pharmacist and the role will be based at the Cape Town Branch and will report to the Quality and Compliance Executive to ensure compliance with the medicines and related substances Act, Act 101 of 1965 and subsequently amended and the Pharmacy Act, Act 53 of 1974 and as subsequently amended.
Requirements:
B. Pharm. DegreeMin 3 Years’ experience in the Wholesale/ Distribution or Pharmaceutical manufacturing industry.Knowledge of GWP/GDP/GMPPharmaceutical Industry Laws and Regulations and Ethics.Current valid registration in good standing with SAPCStaff managementWriting skillExcellent computer skillsKnowledge of ISO standardsLegal Compliance
Duties:
To ensure compliance with Quality & regulatory standards and guidelines.To ensure that all licenses in respect of regulations are maintained for the branch.To maintain the Quality Management System (QMS) by preparing and updating SOP’s, conducting internal and external audits and monitoring staff training.To ensure effective management of product returns, product recall, destruction process and reporting of product complaints/ Adverse eventsTo ensure effective management of CAPAs & deviations and change controls calibration & maintenance of critical equipment.To ensure that product release and sampling are conducted within SLATo ensure that favorable audit reports are received from Distribution principals, to formulate replies to audits reports.To ensure management of the schedule 5 and 6 productsTo ensure that the validation plan is implemented and maintained.To ensure the availability of emergency after hours service.To ensure that there is continuous Pharmacist supervision of premises during operating hours.Responsible for all communication with SAHPRA and SAPC.
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THE ROLE–IN–TRADE GROWTH HACKER:
One of our dynamic forward-thinking clients wishes to appoint an exciting, dynamic, and ambitious individual to join their Food & Beverage Team.
The ideal person is self-motivated and organized, has a positive attitude, and has the drive to want to succeed in building this new and exciting food & beverage category in South Africa. The successful incumbent will form part of the food & beverage division reporting to the Head of Department.
RESPONSIBILITIES
Market research & scoping new on-consumption customersDevelop new ideas about sell-out activities with a creative and innovative spirit, in alignment with the marketing guidelines.POS Tools Management (Ensure the availability and the correct placement of the POS tools, monitoring procurement from HQ and the local productions)
Give support in the implementation of tailor-made tools and concepts.Analyze sell-out results of the POS tools.
Merchandising & marketing asset development & execution and managing supply and qualityMarketing opportunities in on-consumption and off-consumption channelsAnalysis and Planning Activities
Track, record and evaluate all results of implemented marketing activities: POS tools, customers and shoppers activations.Identify potential for improving and adding new marketing activities and proactively involve Sales and Brand Departments.Ensure an efficient allocation of the on-consumption marketing budget and give support to the business planning process.
Managing promotions – instore & externalTraining of outsourced promotional teamsConducting ad-hoc experiential adventure marketing & samplingPresenting key beverage marketing collaborations, sponsorships & partnerships (passive & active sampling events)Presenting key marketing opportunities around trade to drive volumeScoping & Implementing above the line and brand opportunities
QUALIFICATIONS, KEY ATTRIBUTES, AND EXPERIENCE REQUIRED
Qualifications and Experience required:
Post-Matric QualificationTertiary educationA minimum of 3 years experience in Marketing in an FMCG environment essential Valid Code 8 drivers’ licenseSpeak and write English fluentlyBeverage industry experience strongly preferred
Key attributes:
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Ideally my client is looking for someone who has strong Credit Risk and Marketing with most importantly process mapping / process modelling experience.
Job Description
Key Performance Areas:Business Analysis Planning and Monitoring• Identify the appropriate stakeholders• Determine the activities required to successfully complete the business analysis.• Track and communicate the progress of work items throughout the SDLC.• Accurately estimate the required business analysis of work items.• For analysis purposes, have a detailed understanding of the source system (includingaccounting structure, rules and calculations)
Requirements Elicitation, Management and Collaboration• Investigate, evaluate, design and propose solutions to address business requirements.• Validate that the stated requirements match the stakeholders’ expectations.• Work with project stakeholders to identify, model, and then document their requirements andbusiness domain details.• Structure the requirements in the agreed format so that it is understandable by all stakeholders• Ensure the timely analysis and documentation of business requirements for the delivery team.• Strong interpersonal and communication skills to help the team work together and to providea good service.• Communicate the requirements to all stakeholders and obtain stakeholder sign off within theestimate.• Facilitate meetings, give presentations, resolve conflict and negotiate and influence others.• Workshop with a group to capture several independent sources of information relating to theproject, gaining consensus where possible.• Capture areas of opposing opinion.
Requirements Analysis• Ensure that requirements are prioritized.• Use a combination of text, matrices, diagrams and formal models to conceptualise therequirements.• Define Assumptions, Constraints and Risks.• Ensure that requirements specifications meet the necessary standard of quality.• Validate that all requirements support the business architecture.
Solution Assessment and Validation• Ensure that the proposed solution meet the stakeholders’ requirements.• Assist the testing team to ensure the solution is validated against the business requirements• Assess whether the organisation is ready to make effective use of the solution.Enterprise Analysis• Identify new capabilities required to meet the business need.• Define which new capabilities a project iteration will deliver.Life Cycle Management• Act as interface with business and the delivery team during the SDLC.• Understands and can describe the basic function of the business’s core system.
Qualific...
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PROCESS DEVELOPMENT SUPERVISOR, MELT SHOP
SA STEELWORKS
SA Steelworks a Division of the SA Metal Group has a position for a Process Development Supervisor in the Melt Shop department. The position requires an experienced, committed and hardworking individual. The successful candidate will be responsible for process optimisation and the continuous improvement of the plant.
Responsibilities will include, but are not limited to:
Support and assist the Melt Shop ManagerManage and maintain an acceptable quality of work performedProvide Technical/process expertise and leadershipAttend and participate in Production and Engineering meetings when necessaryEnsure audit readiness and deliver high quality products by maintaining the validated status of manufacturing processes.Responsible for leading process improvement strategies for existing product range and tracking cost of goods and process improvement projects.To coordinate all process activities to maintain the process validation programs.To coordinate and assist in the timely execution of trial and validation product runs and ensure that deadlines are met, all correct sampling and data capturing is carried out.To coordinate and assist in the timely sourcing of production equipment/tooling and materials required for new products or as a result of process improvement initiatives.Support the implementation of the operational process program in the Melt Shop by identifying, leading, maintaining and implementing process improvements.To set appropriate objectives for the teams in line with Melt shop needs and ensure appropriate training of all staff to meet competencies on new and existing processes.To adhere to all company and legislative health, safety and environmental requirements.To undertake any additional tasks as assigned by the Melt shop production manager.Ensure that your understand the 24/7 operational needs to facilitate production goals
Applicants must have the following qualifying experience
5 years experience in a Steel manufacturing environment5 years of process management experienceRelevant tertiary qualification will be advantageousAble to work in a pressurized and demanding environmentMust have your own reliable transportMust have a valid driver’s licenseGood communication skillsWork overtime due to operational requirementsAttend to call outs as and when requiredAbility to manage and coordinate a team
We regret that it is not possible to contact all unsuccessful applicants. Applicants who have not been contacted within fourteen (14) days from the date of their submission should consider their application unsuccessful.
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A great opportunity in the pharmaceutical industry. Join their team as a Management Accountant.
Duties include:
Support the Finance Manager and Finance team to assume full responsibility for the full management accounting function.
The management accountant role will be to undertake daily, monthly, quarterly, administrative tasks to ensure the functionality and coordination of the department’s activities to ensure meeting all deadlines.
KEY RESPONSIBILITIES
Management reporting:
Responsible for back flushing raw components within Syspro for MSAUpdate standard costs in the bill of materials within Syspro for MSAReview standard and actual costs for inaccuracies - MSA and AJNSetup and help manage the Inventory module for cost modificationValidate the cost of goods sold as part of the month-end closureAssisting in month-end close of the General Ledger for - MSA and AJNReview of monthly General Ledger Reconciliation file before final review by the Financial ManagerRun general ledger expense accounts in preparation for year-end auditDeveloping and managing financial systems/policiesAssist in managing queries related to the monthly financial results from internal partiesPreparation and submission of monthly VAT returnsMonthly fixed asset register maintenance of MSA and AJN in SysproOverseeing accounting year end processes to meet year-end deadlines
Prepare annual financial statements in accordance with IFRS for year-end
Assist the Financial Manager to prepare and review annual budget requirementInput of budget file into reporting tool for the year aheadProviding insightful financial info for the purpose of decision-making for the business
Financial analysis
Applies principles of accounting to analyse financial information and prepare financial reportsPrepares special financial reports by collecting, analysing and summarising account information and trendsConducts monthly, quarterly, ratio and trend analysisPrepares cash flow forecast modelsReview of Internal COGS for distribution and preparation of GP% analysis, variances investigations and graphs compilation monthlyAssist with and/or lead strategic projects in line with business requirements
PRE-REQUISITES
Relevant Finance qualification in an Accounting / Finance field; or equivalence of having fulfilled a similar role for at least 2-3 years in a deadline driven environment
TECHNICAL COMPETENCIES REQUIRED
Advanced computer literacy (Advance...
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