Sr. QA Specialist

To be a Local Management Representative

To be the Qualified Person (QP) as per local requirement

To be the JDE expert user

To ensure that CQA processes and procedures are in place and in use

Post Market Surveillance (PQC, MDR, FA)

Product traceability

Release of product

Product sale ability

Quality System implementation and maintenance

To ensure appropriate contacts with Regulatory affairs, Pharmacovigilance, PMS, W&D, TS, Business and Third Parties

To be a contact with the Competent Authorities

To act as a contact during internal/ external audits

To ensure that processes and procedures related to the Quality System are in compliance with all applicable regulations ,Quality Manual, EN ISO 9001, EN ISO 13485, GMP, GDP and country specific requirements)

Ability of understanding country specific regulations and general quality requirements

Ability to liaise with different functions involved: e.g. PVS, TS, Regulatory,

Ability to liaise with multicultural teams

Very good spoken and written English

Project management skill

University degree in Scientific (Pharmacy, Chemistry, Biology, Natural Science, Medicine or similar)

QP certificate pharmacy license

proven experience minimum 5 years relevant work experience, with at least 3 years in a Quality Assurance role.

please specify jb-184

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