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Pelltech Health Care Pvt. Ltd. is a WHO-GMP CERTIFIED PHARMACEUTICAL MANUFACTURING COMPANY with dedicated state-of-art facility for Manufacturing high quality conventional & modified released Pellets and finished dose packages in (Pellets) capsules & tablets. The plant is located 70 kms from the transport hub to domestic as well as International Destination from Mumbai, INDIA.
Post: QA Manager
Job Responsibilities:
1. To ensure implementation of current GMP & GLP norms in manufacturing and testing areas respectively.
2. To approve or reject, starting materials, packaging materials, and intermediate, bulk and finished products.
3. To release or reject the batch of finished product for sale and / or distribution.
4. To evaluate batch records.
5. To ensure that all necessary testing is carried out.
6. To approve specifications, sampling instructions, test methods and other Q.C. procedures.
7. To approve and monitor any contract analysis.
8. To check the maintenance of the department, premises and equipment.
9. To carry out the self-inspection as a member of self inspection team.
10. To establish, lay down and implement various systems, SOPs and documentation as per current GMP systems.
11. To ensure that the appropriate validations are done
12. To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need.
13. To correspond with relevant drug control authorities and fulfilling legal requirements.
14. As senior member of management team, participate and contribute in achieving company objectives, as directed by the management from time to time.
Candidate Profile:
For QA: M.SC- CHEMISTRY , B.PHARM , M.PHARM , Knowledge of Quality management systems , Process validations., Cleaning validations, water validations, HVAC validations. Should have knowledge of Schedule M and WHO requirements. Should be able to independently take decisions. facing inspections
Additional Information:
Experience: 5-10 years
Location: Mumbai, Thane
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Send your applications on, hr@pelltechhealthcare.com
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