QA Compliance Pharmacist

June 21, 2023

Aspen Pharma Group

Port Elizabeth

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 c GMP.
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.
Applying for Import permits/authorisation for all Schedule 5 and 6 medicines handled by the External Supply (ES) department for the SA market.
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 requiredRequirements

Continuous Improvement Initiatives

Identify gaps within the current processes and investigate and propose ways to close those gaps.
Identifying ways to streamline processes, resulting in quicker turnaround of QA activities.
Manage projects assigned to you as per guidelines from the manager and as per agreed timeframes.
Regularly provide feedback on progress of projects and highlight any issues that require manager’s attention.

HUMAN RESOURCES Compliance to Labour Legislations and In-house Best Practice).

Familiarise yourself with and at all times act in accordance with the company policies and procedures.

GMP COMPLIANCE

Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities.
Ensure that products are handled according to the required SOP’s and documentation.

Health, safety and environmental standard

Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
Report any unsafe or unhealthy situations to SHE representative or Line Manager
Report any incident to the SHE representative or Line Manager which may affect your health or cause injury

Background/experience