Manager – Corporate Quality Assurance (P2P)

from 10 to 12 year(s) of Experience
Not Disclosed by Recruiter

Job Description

Responsibilities:-

1. Evaluation of new proposal and projects towards commercial suitability

2. To review and approve the QMS documents generated at contract manufacturing sites.

3. To schedule audit plan of contract mfg. sites on yearly basis based on business / project proposals and priorities.

4. To inspect contract manufacturing sites as per schedule and monitor GMP compliance

meeting regulatory requirements of respective market.

5. To Review and Assess the data received from all such sites to ensure compliance to GDP/ GLP.

6. To monitor validation and qualification activities performed at sites and ensure their compliance to the cGMP guidelines.

7. To ensure compliance of CAPA on the observations noted during various regulatory inspections performed at P2P sites.

8. To Review Investigation reports of market complaints and ensure appropriate CAPA based on root cause identified.

9. To ensure compliance and closure to various queries received from regulatory authorities or customers through co-ordination with Regulatory Assurance department.

10. To enhance co-ordination with supply chain to ensure getting documents from P2P pertaining to complaints, CAPAs or any changes which directly or indirectly impacts business timelines.

11. To travel and visit to warehouses and / or CnFs for investigation and auditing the facility.

12. To review stability data being generated at P2P sites and monitor trend of OOS/OOT , if any.

13. To provide Trainings to the personals from each contract manufacturing site in terms of documentation or regulatory requirements as and when required.


Role:Quality Assurance/Quality Control Manager

Salary: Not Disclosed by Recruiter

Industry:Pharma, Biotech, Clinical Research

Functional AreaProduction, Manufacturing, Maintenance

Role CategoryProduction/Manufacturing/Maintenance

Employment Type:Full Time, Permanent

Education-

UG:B.Pharma in Any Specialization,B.Sc in Any Specialization

PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization

Doctorate:

Company Profile

J B Chemicals and Pharmaceuticals Ltd.

Established in 1976, J.B. Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India’s fastest growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally. Today, JBCPL exports to over 30 countries across the world and earns more than half its revenue from its international business.
JBCPL is widely committed to manufacturing a range of innovative specialty products that include various pharmaceutical dosage forms like tablets, injectable (vials, ampoules, form fill seal), creams & ointments, lozenges, herbal liquids and capsules.
JBCPL has its headquarters in India’s financial capital, Mumbai. With a domestic sales force of 1,000 people, 17 internationally approved state of the art manufacturing units, a Research and Development Centre, and subsidiaries abroad, the organisation is continually enhancing value for its shareholders.
In India and International markets, JBCPL is also known as Unique Pharmaceutical Laboratories and is a division of JBCPL.
Company Info
View Contact Details+

Contact Company:J B Chemicals and Pharmaceuticals Ltd.

Address:UNIT A2,8th FLOOR,CNERGY IT PARK,APPA SAHEB MARATH, E MARG,WORLI PRABHADEVI, , MUMBAI, Maharashtra, India