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297 Piramal Pharma Jobs

Deputy Manager - Quality Assurance

9-13 years

Mumbai

1 vacancy

Deputy Manager - Quality Assurance

Piramal Pharma

posted 5d ago

Job Description

  1. To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers.
  2. To review the process validation/ cleaning validation qualification protocols.
  3. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products.
  4. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution.
  5. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system.
  6. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program.
  7. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically.
  8. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements.
  9. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits.
  10. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements.
  11. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility.
  12. To ensure completion of APRs of products and take appropriate actions in case of deviations.
  13. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods.
  14. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition.
  15. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site.
  16. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures.
  17. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively.
  18. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals.
  19. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111.
  20. Ensuring avoidance of breach of data integrity at all the levels.
  21. Ensuring implementation of effective sanitation activities at all the levels.
  22. Imparting required training to shop floor personnel.
  23. Adherence to the requirements of EHS norms.
  24. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items.
  25. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA.
  26. To perform MSC2N transactions in SAP.
  27. Review of Change Control, Deviation, CAPA in trackwise.
  28. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
  29. SOP, BMR/BPR, layouts, STP review and approval in ENSUR system.
  30. To conduct vendor audits for RM/PM.
  31. To lead and guide the IPQA team for shopfloor activities.
  32. To set, review and evaluate KRA of reportee s.
  33. To share the RR nominations of team members on quarterly basis.
  34. To identify and implement the OE projects.
  35. Patient/ Customer centricity.
B. Pharm/ M. Pharm

Employment Type: Full Time, Permanent

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Top Piramal Pharma Deputy Manager Quality Assurance Interview Questions

Q1. What is the difference between discriminatory media & bio relevant media?
Q2. What is GMP ?,what is change control system ?
Q3. How will you perform method precision for Related substances method?
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What people at Piramal Pharma are saying

5.0
 Rating based on 1 Deputy Manager Quality Assurance review

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Employee caring company

  • Salary - Good
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Deputy Manager Quality Assurance salary at Piramal Pharma

reported by 4 employees with 9-14 years exp.
₹6.5 L/yr - ₹11.4 L/yr
24% less than the average Deputy Manager Quality Assurance Salary in India
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What Piramal Pharma employees are saying about work life

based on 988 employees
53%
41%
52%
96%
Flexible timing
Monday to Saturday
No travel
Day Shift
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Piramal Pharma Benefits

Submitted by Company
Free Transport
Soft Skill Training
Job Training
Health Insurance
Submitted by Employees
Health Insurance
Free Transport
Job Training
Free Food
Soft Skill Training
Cafeteria +6 more
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Piramal Pharma Mumbai Office Location

View all
Mumbai, Maharashtra Office
Headquarter
Kamani Junction, LBS Marg, Piramal Ananta, Agastya Corporate Park, Kurla, Maharashtra 400070, IN Mumbai, Maharashtra
400070

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