A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Executive Quality Assurance
Job Description:
1. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy
2. Ensure compliance with Pharmacopoeia/Group requirements / local and International authorities.
3. Having experience of Analytical Method Validations.
4. Issuance of GMP documents
5. Receipt of validation related documents
6. Investigation Knowledge to carryout OOS/OOE/OOC & Deviation
7. To ensure the timely evaluation/review/approval of change Controls
8. Io support self f-inspection as per predefined schedule.
9. Ensure timely notification /Management escalation & reporting of potential quality defects that arise and may affect product on the market
10. To assess the need for expediting closure or extension of CAPA’s assigned to group.
11. Participate in intra and inter departmental meetings and communications to fulfil the company's objectives.
12. Ensure timely notification or reporting of potential quality defects that arise and may affect product on market, is a key element of compliance with country regulation and more importantly a behavior which can establish a positive quality relationship with Health authority.
13. To provide support to customer /authority inspections.
14. To ensure the timely archival and retrieval of relevant documents.
15. To support the regular inputs of Quality event (OOS/OOE/ Déviation etc.) Investigation matrix.
16. Ensure the company's adherence to the required norms of local and international authorities/group guidelines
17. Maintain confidentiality, ensure safety custody and efficient handling of company document and material.
Candidate Profile
Master in Science/ Masters in Pharmacy/Bachelors in Pharmacy English 5-7 years
Additional Information:
Experience: 5-7 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Quality
Job ID: 226806BR
Last Date: 1st December, 2017
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