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Qa Pharmacist Midrand
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General Details
Description
Our Client is looking for a Quality Assurance Pharmacist who has the responsibility to oversee all key elements of the Quality Management system (QMS) and monitor its effectiveness. The role ensures quality standards and current procedures meet regulations for GxP.
1. QUALITY ASSURANCE:
• All the Companies various departmental SOPs reviewed, revised and updated and correctly authorised.
• Manage all QA departmental functions as listed, but not limited to:
- QA document control
- Site Master File
- Quality Manual and Quality Policy
- Implement the Validation Master Plan
- Approve and manage approved suppliers list
- Internal and External Audits and any deviations are followed up
- Liaise with service providers regarding QA matters
- Non-conformance (Deviations and OOS) documentation and investigations
- Adverse Drug Reaction (ADR) support
- Root Cause Analysis (RCA)
- Corrective and Preventative Actions (CAPA)
- Change Controls
- Process validations
- Method validations
- Product Quality Reviews
- Quality Management Review (QMR meetings)
- Ensure adequate pest control program is in place
- Approval of specification sheets for release
- Ensure Technical Quality Agreements exists between Pharmaforce and 3 rd party contractors/service providers regarding responsibilities.
- Implement Stability Master Plan
2. COMPLAINTS
• To ensure that all product quality complaints are identified, investigated and dealt with correctly.
3. RECALLS
• To ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.
4. RETURNED / REJECTED GOODS
• To ensure that goods returned are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
• To ensure that goods due to be rejected are handled in a procedurally correct manner.
• Final decision to re-analyze, re-pack or destroy any returned/rejected goods.
5. GMP/GWP/GHP
• To ensure that inspection audits are performed on all third-party contractors whereby it is established that:
- all manufacturing operations are carried out in accordance with approved, written GMP and manufacturing procedures.
- the products as manufactured meet the specifications of the registration dossier and approved specifications.
- that the specified quality is maintained during storage and transport.
- that a contract packer has adequate packaging facilities, and that written systems are adhered to until delivery of the final packaged product for release for distribution.
• To ensure that all logs are completed by the distribution / warehousing facility e.g. temperature control, cleaning, maintenance etc.
• To ensure that disposal or destruction of medicines is correctly performed under proper control so as not to be a health hazard.
• To ensure that an adequate pest control program is in place at the distribution facility, usin
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Id Subtitle 1094956243
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