Quality Assurance Manager

6 days ago

Jeddah, Saudi Arabia Acino Full time

University degree in Pharmacy, Chemical Engineering or Chemistry
- Minimum of 5 years’ experience in Pharma QA experience is required
- Excellent communication skills in English
- In-depth knowledge of cGMP& cGLP& cGDP
- Perform and document QA Due Diligence on distributors and service providers according to corporate process.
- Monitor and report monthly KPIs such as audit execution vs plan, implementation of QMS.
- Keep up-to-date with the relevant regulations, quality directives and guidelines.
- Coordinate, organize and execute external GDP/GMP customer audits within the META region.
- Participate in Authority site inspections and follow-up on observations.
- Responsible for all Quality-related activities in Egypt.
- Control batch records and release batches timely
- Create and maintain the local Quality Management System (QMS) including Master documents, SOPs etc.
- Create/approve deviation, CAPA, change control, complaint reports or other quality relevant documents.
- Perform risk assessment of supplier’s and distributor’s qualification, which is required for the preparation of the annual audit plan.
- Implementation of QMS, TQAs and all other Quality related documents. Create, review and negotiate Technical Quality Agreements with contract manufacturing organizations and service providers.
- Assessment of PQRs.
- Coordinate product launches and transfers from QA perspective.
- Support quality training to all Egypt employees.
- Experience in department management and strong people manager
- Proficiency with personal computers, business and technical software
- Can work self-organized as well as with remote organizations
- Excellent organizational, time management, and prioritization skills
- Ability to work in an international environment using effective interpersonal, networking and negotiation skills

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