Quality Assurance Manager (Pharmaceutical)
Purpose of the Job: Responsible for management of quality systems and related standard operating practices. To ensure that the company Quality Manual and Quality Management System is effectively implemented into all aspects of the manufacturing process.
1. Management, training, coaching and development of department’s staff
2. Ensuring GMP compliance with regard to regulatory, customer and in-house requirements
3. Driving best GMP quality standards across the business to all employees at all levels.
4. Lead and facilitate the internal and external audit/ inspection programme for the plant which includes Corporate, Customer and regulatory inspections (MCC, TGA, EU)
5. Overseeing the handling of product failures and anomalies - Investigation into root causes, effective implementation of corrective/preventive actions as well as recording and trending of data
6. Control and review of all the systems of the Quality Management system, e.g. Deviations, CAPAs, Document Control, Risk Assessment and Change Control
7. Establishing quality metrics, data collection, trending and analysis of KPI’s
8. Compilation of Document Audits and Annual Management review for ISO 9001 certification.
9. Involvement with project decisions which may affect the quality of the product
10. Overseeing the Complaints Handling Process
11. Lead the Vendor Management programme
12. Overseeing and co-ordination of Product Recalls
13. Managing the overall PQR (product quality review) process in accordance with GMP requirements.
14. Reviewing and approving Validation/Qualification protocols and reports, including associated risk assessments and deviations
15. Leads the Documentation Management process which includes the reviewing and approving of SOPs
16. Managing and driving the self-inspection programme
Able to work unsupervised
Accurate with attention to detail and ability to identify risk
Able to function effectively under pressure
Strongly motivated by challenge and ability to work well as part of a team
Perseverance and someone who is proactive
Quality mind-set, always looking for improvement and best practice
Takes full ownership of Quality Issues and sees them through to completion
Relevant diploma / degree in Pharmacy, Science, Microbiology, Chemistry or Quality
Profound knowledge of GMP regulatory requirements and ISO9001 standards
Demonstrated ability of driving GMP compliance at all levels in a large organisation
5 to 10 years relevant pharmaceutical/ sterile manufacturing experience
Experience / strong interest in product problem solving and continuous improvement
Management experience within a quality function