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Wednesday, December 22, 2010

MANAGER - QUALITY ASSURANCE (Dry Powder Injection)

Summary

Experience:
6 - 8 Years
Location:
Baddi HP
Compensation:
Best in the industry..
Education:
UG - B.Sc - ChemistryPG - M.Sc - Chemistry
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
QA/QC Mgr
Functional Area:
Production, Maintenance, Quality
Posted Date:
21 Dec

Desired Candidate Profile

Appropriately qualified candidates, with relevant experience in Dry Powder Injection facility. Hands-on experience in managing international regulatory inspections is essential requirements. Candidates with minimum 6-8 years experience in Injection Manufacturing may apply.

Job Description

- To maintain cGMP level on shop floor (24x7 Quality Management System ).
- BMR issuance & review, line/area clearance, monitoring of Critical process

Parameters
- Review of DRAFT Documents like: Batch Manufacturing Record (BMR), Master

Formula Card (MFC), Master Packing Docket (MPD), Product Development

Report (PDR)
- API/ Finished Products Batch sampling & release activity
- Stability: Protocol, sample preparation, data review
- Retain/ Control sample management
- Training to shop floor team of QA and Production
- Cleaning Validation: Protocol, sampling, review and report
- Process Validation: Protocol, sampling, review and report
- Qualification Activity: Production Equipment's and Utility
- cGMP documentation w.r.t. shop floor activity
- SOP: preparation, review and Compliance
- Co-Ordination with support functions like : Production, Engineering, Utility, Ware house etc.
- To specifically manage Key Quality Management processes such Management Review, Customer Complaint Handling, CAPA and Internal Audits and to manage all external audits of the company including Notified Body, FDA and Customer Audits

 
Keywords: quality assurance, manager, quality, pharma, biotech, research, qaulity, production, injection, CAPA. FDA.

Company Profile

Zeiss Pharmaceuticals is a leading Dry Powder Injection manufacturing Company, with an annual turnover of approx. Rs. 150 Crores. The facility is accredited by international agencies and follows current Good Manufacturing Practices, as per WHO guidelines. We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.
Contact Details
Company Name:
Zeiss Pharma
Website:
Not Mentioned
Executive Name:
Manager H R
Address:
Zeiss Pharma
PLOT NO. 72 EPIP-I JHARMAJRI BADDI,
CHANDIGARH,Chandigarh,India 160017
Email Address:

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