QA Compliance Pharmacist

5 months ago

Port Elizabeth, South Africa Aspen Pharma Group Full time

**Overview**
- Monitor manufacturing compliance to GMP and statutory requirements
- Monitor adherence to guidelines, procedures and document controls
- Deliver expected value stream targets as per business requirements
- Facility GMP compliance
- Team and process development

**Responsibilities**

**General Operating Activities**
- Execute daily tasks and work instructions according to the relevant SOP's.
- Operate computer systems by capturing data, printing standard reports, etc.
- Perform reconciliations of data
- Update and maintain databases
- Edit and format SOP’s as and when required.
- Generate reports as per instruction
- Verify and interpret the accuracy of data and audit documentation
- Ensure that all relevant documentation gains the necessary signatures for completion
- Maintain accurate filing and retrieval of documentation
- Perform any other tasks relating to your work as and when required

**Final Release of all External Supply Products**
- Review of batch documentation, i.e. Executed batch documents, Post-Importation test results, etc. for compliance to GMP and master documents as per product dossier.
- Review of product samples and artwork, where applicable for SA Markets.
- Ensure that Post Importation Testing (PIT) (where applicable) is being adequately managed.
- Monitoring blocked stock at the different warehouses on continuous basis.
- Ensure product release is conducted as per SOP for SA and International Markets.
- Management of product re-works according to SOP and cGMP.
- Review of data logger downloads for product's received in country.

**Investigating and resolving QA Queries**
- Conduct and request feedback and/or reports on QA queries from Manufacturer and discuss with QA Management team.
- Follow up on outstanding documentation such as reports and deviations.
- Approval of deviations and logging deviations received from CM in consultation with QA management team.
- Management of laboratory Out of Specifications (OOS) in consultation with the lab and CM.
- Handling of Suspect Stock Notifications from the Aspen warehouses to ensure they are investigated correctly and do not recur.
- Review of temperature excursions for products during transportation or storage from manufacturer, distributors, or customers in consultation with QA Management team.
- Review of raw materials status at the CM in terms of expiry date, re-testing, etc. as per SOP and assisting in resolving any queries regarding RM’s
- Updating of Baan system with regards to expiry date of stock, where applicable.

**Control of highly scheduled Substance**
- Completion of S6 requisitions for samples requested.
- Logging of samples received in the S6 register.
- Balance of S6 Register as per Medicines Control Council (MCC) requirements.
- Identifying new products to be launched that will require a permit and performing the necessary set-up with the MCC.
- Conducting regular meetings with the Logistics department to ensure that all S5 and S6 medicines coming into SA have permits.
- Ensuring that the permits are customs cleared once the product is in country, performing the necessary reconciliation and sending the permits back to the MCC as per agreed timelines.

**Management of QA activities for new product launches and re -alignments**
- Requesting Finished Product Testing documents from Regulatory Authority (RA) department and providing these to the potential PIT labs for quotation, where applicable.
- Assisting in resolving any queries arising with the PIT lab and RA/Aspen technical team.
- Reviewing the PIT quotations from the labs and advising the QA manager as to the most appropriate option.
- Co-ordinating the Analytical Method Transfer (AMT) with the selected PIT laboratory for New product launches and Re-alignments, where required.
- Oversee that the Reference standards, Columns and other materials needed by the PIT lab are ordered timeously to prevent delays in testing of new launch products.
- Ensuring the master documents and executed documents are requested and received timeously from the supplier as part of the launch/re-alignment process.
- Review of the full batch documentation for the 1st two batches of a new product launch or re-alignment for compliance to GMP and product dossier.

**QMS Metrics - SOP’s, deviations & change controls and reporting**
- Initiation and review of SOPs relevant to work function.
- Completion of the sections in the QSMR relevant to batch release and lab management.
- Logging of internal deviations on the Trackwise system and management thereof to ensure that adequate CAPA's are in place to prevent future recurrence on non-conformances.
- Review of external deviations and making recommendations as to actions to be taken.
- Completion of action items assigned on Change Control on Trackwise.
- Performing internal audits as and when required.
- Compiling AD-hoc reports as and when required**Requirements**

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**Continuous Improvement Initiatives**

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- Identify gaps wi

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