Quality Assurance Manager - Alexandria

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Bourj Alarab, AlexandriaPosted 5 years ago

125Applicants for1 open position

Job Details

Experience Needed:

Career Level:

Education Level:

Salary:

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Prepare, implement & review quality system following the company QMS, applicable regulations & requirements to assure quality of API.
Plan and provide support to manufacturing activities as per QMS and GMP guidelines.
Management & control of SOPs, Master documents, labels & other GMP impacted documents.
Review of Batch Manufacturing Records (BMRs), Analytical record & related documents.
Deviation Investigation. Change control review & management. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling & non-standard batch size procedures as per applicable SOPs.
Responsible for approving changes that potentially impact intermediate or API quality.
Responsible to make sure that quality related complaints are investigated and resolved.
Responsible to make sure that materials are appropriately tested and the results are reported.
Ensure the preparedness of system or record for external inspections or audits from regulatory agencies or certifying agencies.
Ensure implementation of corrective & preventive actions proposed in deviation/ failure investigations, audit/ inspection compliance and responding to queries.
Ensure that the internal audits (self-inspections) are performed as per the schedule.
Develop cGMP training modules & impart training.
Identifying & correcting unsafe conditions or behaviors & promptly reporting other potentially hazardous situations.

Qualifications & Experience

Sc. in Pharmacy or Science, preferably MBA holder.
+10 years of experience in QA in the multinational pharmaceutical companies with related experience in QC, Manufacturing, Regulatory affairs.
Must be previously subjected to inspections from foreign regulatory bodies as WHO, MHRA, EMA, FDA with favorable inspection outcomes.
Willing to relocate

Technical skills & Competencies / Language

Knowledge of GMP, GLP & other relevant GxP and Regulatory International Guidelines.
Leadership skills.
Analytical ability.
Planning ability.
Communication skills.
Problem solving.
Team building.