COMPLIANCE LABORATORY QUALITY REVIEWER - Aspen Pharmacare - Gqeberha, Eastern Cape
(2021-12)
- Ensure compliance within the OSD Quality Control lab, maintaining high standards in line with industry regulations and internal protocols.
- Lead external audit preparations, taking notes, organizing documentation, and participating in audit closeouts to address findings and implement necessary changes.
- Develop and implement new SOPs, streamlining laboratory processes, improving clarity, and addressing any identified compliance gaps.
- Conduct data integrity audits, identifying areas for improvement and driving corrective actions to maintain the highest data accuracy standards.
- Drive cross-functional compliance projects in the QC lab, ensuring timely and effective completion of CAPAs, deviations, and change controls in line with regulatory expectations.
- Facilitate training sessions to address compliance gaps, enhancing team knowledge of quality protocols and fostering a culture of continuous improvement.
- Conduct regular compliance walkthroughs, identifying issues and providing constructive feedback to management to improve operational quality.
- Manage the retrieval and organization of AL workbooks, performing data integrity checks and ensuring compliance prior to storage.
- Follow up on overdue compliance items, ensuring that Change Controls, CAPAs, and Deviations are closed out promptly and accurately.
- Participate actively in QMS meetings, providing insights on compliance matters and ensuring action items from external and internal audits are tracked and addressed.
METHOD AND SPECIFICATION EVALUATOR - Fresenius-Kabi - Gqeberha, Eastern Cape
(2021-01 - 2022-11)
- Evaluated pharmacopeia standards (USP, BP, EP) against site Method of Analysis (MOA) to identify and address gaps for raw materials and components.
- Initiated, investigated, and completed change controls related to method and specification updates, ensuring compliance with industry standards.
- Drafted and managed testing protocols for raw materials, finished products, and stability tests based on relevant pharmacopeia or dossier requirements.
- Oversaw the issuance, retrieval, and obsoletion of MOA documents in the lab, ensuring proper documentation control and submission to relevant departments.
- Managed compliance projects, ensuring timely execution and alignment with regulatory requirements and internal quality standards.
- Reviewed and evaluated analytical data to assess the effectiveness of documented MOAs and identify areas for improvement.
- Addressed queries from Regulatory Affairs regarding method of analysis updates, collaborating to ensure accurate and timely project adjustments.
- Liaised with Regulatory Affairs teams across multiple Fresenius-Kabi sites to ensure consistency and alignment in method specifications.
- Participated in internal and external audits, supporting the completion of audit tasks and the closure of findings related to methods and specifications.
- Managed and populated change controls on Kabitrack, ensuring accurate tracking of method and specification changes and their impact on site operations.
QUALITY OFFICER - Aspen Pharmacare - Gqeberha, Eastern Cape
(2013-03 - 2020-06)
- Ensured compliance across the entire GPU department, identifying areas of improvement and driving the implementation of corrective actions to meet regulatory standards.
- Reviewed and updated SOPs, ensuring all procedures were aligned with current guidelines and best practices, enhancing operational efficiency and compliance.
- Developed and provided training packs for laboratory staff during procedure updates, ensuring thorough training and full compliance across all departments.
- Eliminated obsolete standard forms, replacing them with effective and up-to-date documents, improving the accuracy of documentation and minimizing errors.
- Monitored and ensured the accuracy of equipment use logs, reagent lists, and standard procedures, ensuring the laboratory met quality control requirements.
- Created and executed internal audit checklists for the GPU department, conducting regular audits across 16 departments to ensure compliance with internal and external standards.
- Coordinated and participated in external audits, leading preparation efforts and being the main point of contact during audits, ensuring a smooth and successful audit process.
- Conducted internal audits, writing audit reports, addressing audit findings, and driving the closure of non-conformance issues to strengthen quality control processes.
- Performed weekly laboratory walkthroughs, providing management with detailed reports on lab operations and areas for improvement.
- Developed and maintained an annual audit schedule for the entire GPU department, ensuring that audits were planned, executed, and reported on time.
SENIOR SPECIFICATION EVALUATOR - Aspen Pharmacare - Gqeberha, Eastern Cape
(2009-06 - 2013-02)
- Compiled and maintained specifications and methods of analysis for raw materials and finished products, ensuring compliance with industry standards.
- Updated specifications for raw materials and finished products, aligning methods of analysis with the latest pharmacopoeia and regulatory guidelines.
- Provided expert input on specification updates, identifying resource requirements and optimizing processes to ensure the smooth integration of new standards.
- Transferred analytical evaluation data into specifications and methods of analysis.
- Prepared launch specifications for purchased products, utilizing dossiers and supplier certifications of analysis to ensure products met all quality and regulatory standards.
- Evaluated existing specifications against the latest pharmacopoeia, ensuring continuous alignment with evolving regulatory requirements.
- Initiated and managed change control processes and deviations, using both manual methods and Process Compliance software to track and resolve discrepancies.
- Performed comparative assessments of Certificates of Analysis (COA), monographs, and current specifications to inform procurement decisions and ensure product quality.
- Evaluated raw materials against the latest monographs, identifying any deviations or compliance issues to ensure the integrity of the production process.
- Reviewed LIMS reports, ensuring data accuracy and compliance with quality standards.
STABILITY ANALYST - Aspen Pharmacare - Gqeberha, Eastern Cape
(2007-01 - 2009-05)
Instruments used: HPLC, GC, UV/VIS, Karl Fischer, Microscope, Halogen Lamp Analyser, Spreadability, Densitometer, Dissolution Bath, Viscometer (Brookfield and Haake), Friability, Drop Point, AA Spec, Disintegration, Rheometer, Titrino, Centrifuge, Refractometer, Optical Rotation, FTIR, Malvern Mastersizer 2000, Polarimeter.
- Developed and executed testing schedules to ensure timely and efficient stability testing in line with monthly plans, optimizing laboratory workflows.
- Prepared and processed samples for stability analysis, adhering to quality and procedural standards to ensure accuracy and consistency in results.
- Customized chromatography and summary reports to meet testing requirements, enhancing the precision and clarity of data for decision-making.
- Reviewed and approved raw data to ensure compliance with GLP and ISO standards, maintaining high levels of accuracy and integrity in lab reports.
- Utilized a wide range of analytical instruments (HPLC, GC, UV/VIS, etc.) to perform complex stability tests, ensuring precise and reliable results.
- Maintained lab health and safety standards, ensuring compliance with all safety protocols to support a safe and efficient working environment.
