Novartis
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.
Job Title: Assistant Manager Quality Control
No. of Posts: 1
Job Description:
Position Purpose :
Responsible for ensuring compliance to :
i.Good Manufacturing Practices (cGMP) for the laboratory
ii.Health, Safety & Environment policy
iii.Pharmacopoeia, Group requirements, local and International health authority guidelines
Major Accountabilities:
1. Ensure effective planning and prioritization of all microbial testing to ensure strict adherence to schedules and supply chain requirements.
2. Evaluate and support implementation of current industry best practices for effective and compliant functioning of the Microbiology laboratory.
3. Ensure effective management of all samples received in the lab as per SOP and support effective work allocation to Analyst.
4. Actively monitor and support continuous improvement initiatives for the lab. 5. Ensure effective inventory management of Laboratory consumables.
6. Prepare and monitor calibration / qualification /preventive maintenance schedules, including AMCs.
7. Prepare and monitor environment monitoring, water, compressed gas testing schedules.
8. Monitor and support cleaning validation activities (microbial parameters).
9. Participate and actively support laboratory investigations, deviation, change control reporting and laboratory documentation.
10.Design, review and maintenance
11. Actively monitor Analytical Method Transfers, Microbial Method validation activities.
12.Review / revise raw material and product specifications for microbial parameters, as required.
Qualifications:
- Postgraduate in Microbiology, Biotechnology, Biochemistry, Life sciences English
- 8 – 10 years of work experience with minimum 3 years of relevant experience (experience in aseptic manufacturingwould be an additional benefit)
- Good MS-Office skills
- Good analytical, presentation & communication skills Self-starter
