QA Specialist At Minapharm Pharmaceuticals
Quality Assurance Specialist (Compliance / Validation) At Minapharm Pharmaceuticals
About the job
About Minapharm:
Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 lifesaving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
Our Values:
Diversity & Respect
Integrity & Accountability
Collaboration
Leadership & Empowerment
Innovation & Continuous Learning
QA Compliance Specialist Job Summary:
Perform all quality assurance compliance activities including but not limited to GMP and pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, PQR, complaints, quality risk management and GMP training.
QA Validation Specialist Job Summary:
To execute qualification and validation for all manufacturing and cleaning procedures.
QA Compliance Specialist Duties & Responsibilities:
Participate in update procedures relevant to pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, quality risk management and GMP training.
Participate in annual internal audit schedule, prepare internal audit reports, send approved internal audit reports to owners, agree with owners on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of internal audit QKPIs.
Participate in audits of supplier / contractor / contract acceptors, prepare audit reports, send approved audit reports to supplier / contractor / contract acceptors, agree with them on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of supplier / contractor / contract acceptors audit QKPIs.
Ensure that all employees (permanent, temporary) and contractor / visitors receive required GMP training before they independently certified to perform their tasks independently.
Prepares a register of qualified trainers, participate in preparation of training programs, participate in evaluation of training effectiveness and quarterly report status of GMP training QKPIs.
Participate in all quality risk management activities with cross-functional teams of SMEs. Follow-up closure of all actions required to reduce risks to an acceptable level and evaluate effectiveness of these actions through after-action risk review. Quarterly report status of quality risk management QKPIs.
Work with cross-functional team to develop and maintain site contamination control strategy. Prepare a quarter report indicating status of contamination control strategy and its effectiveness in controlling contamination and cross-contamination risks and recommendations for improvement.
Perform PQR data collection, review, analysis and reporting for all manufactured products. Set recommended actions and required SMART CAPA with follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of PQR reports in QKPIs.
Handling of received Customer Complaints ( starting from receiving of complaint, numbering, evaluation and investigation, impact assessment, set SMART CAPA, immediate action and CAPA follow up, closure and trending )
Participate in different multidisciplinary teams and relevant activities as required.
QA Validation Specialist Job Responsibilities:
Follow equipment calibration plan and coordinate with concerned departments to perform qualification/validation activities.
2. Witness equipment qualification/calibration activities and review qualification documents and calibration certificates supplied by external service providers.
3. Prepare protocols, execute qualification protocols and report outcomes for process and cleaning validation in addition to Equipment / Utilities qualification.
4. Issue new SOPs and revise SOPs as requested.
5. Record incidents, deviations, changes and participate in the investigation and assessment.
6. Implementation of CAPA, additional controls, change control actions, annual report actions, management review actions.
7. Execute quality risk management-projects, health and safety risk-assessment and environmental aspects & impacts.
8. Perform on-site training sessions as relevant.
Needed qualifications:
1-3 years in pharmaceutical industry preferably experience in quality operations & in sterile manufacturing, hands on experience in validation activities.
Minimum BSc in pharmaceutical sciences is a must.
GMDP requirements for sterile biological products.
Ability to implement and follow-up of validation or qualification requirements.
Ability to evaluate data generated from validation studies.
Basic GMP.
Proficiency in English language.
Job Location: 10th of Ramadan.
Transportation is provided.
Medical Insurance.
Life Insurance.
Profit share.