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
