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Accountable for the quality and GMP/GDP, ISO13485 compliance of:
•Reporting quality performance indicators to Head of Regional Subsidiaries Quality and take leadership in the performance of Quality Management Reviews.
•Escalation to Regional Head any critical Quality issues.
•Defend Merck positions regarding quality issues at the local Health Authorities.
•Preparing and coordinating Health Authority inspections including GDP/GMP/ ISO13485 inspections.
•Create internal and external audit plan, program and audit execution by qualified auditors per risk approach.
•Ensure the Quality of the products put on the market.
•To ensure that product released on the market is in compliance with the GMP/GDP/ ISO13485, local law requirements and product specifications.
•Releasing products delivered to the subsidiary and assure the products are manufactured in line with the Marketing Authorization.
•Implementation and management of quality documents.
•Review and approval of quality documents.
•Training of local personnel on locally implemented quality systems and GMP/GDP/ ISO13485 matters (training program, training record).
•Provide technical training to affiliates partners to ensure efficient development plans and appropriate expertise.
•Coordinating product recalls and withdrawal of the local country, including investigational medicinal product (IMP) and marketed medicinal products
•To recognize a reportable adverse event or safety information and having the necessary information forwarded to the Local Drug Safety Contact.
•Handling of GMP/GDP/ ISO13485 deviations (including receiving, recording, investigating and closing out).
•Handling of GMP/GDP/ ISO13485 Changes control.
•Assuring Quality critical changes are documented according to a formal Change Control process and that the appropriate actions are taken before implementing the changes.
•Handling and escalation of complaints received from costumers (including receiving, recording, investigating and closing out).
•Assuring corrective and preventive actions (CAPA) are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes.
•Assuring GMP/GDP critical vendors are qualified (maintaining a vendor list, establishing Technical Agreements with the vendors, assuring vendor are regularly monitored / followed up).
•Provide support and monitor quality issues to resolution within the organization and external suppliers.
•Where applicable, to capture, record and forward the information to the local Pharmacovigilance.
•Review and approval Packaging materials as QA representative.
•Support local and regional teams for projects as quality representative.
Who you are:
•Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology)
PROFESSIONAL & TECHNICAL SKILLS
•Minimum of 5 years work experience in quality assurance and/or quality control and/or production/distribution in the pharmaceutical industry
•Thorough knowledge of GDP and applicable local regulations
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com