Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Monday, December 13, 2010

Manager QA - Validation Impact HR Services

Summary

Experience:
7 - 12 Years
Location:
Nasik
Education:
UG - B.Pharma - PharmacyPG - Post Graduation Not Required
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
QA/QC Mgr
Functional Area:
Production, Maintenance, Quality

Desired Candidate Profile

B Pharma with 7-12 exp in QA

Job Description

Heading the Quality assurance dept. for all plant activities.

Responsible for FDA and regulatory Audits.(Compliances CAPA)

Preparation of standard operating procedures and reviews.

Preparation and review of validation protocols and reports.

Equipment qualifications and validation

Handling of product complaints, deviations & change controls and reporting.

Process validations.(Manufacturing & packing validations)

Area qualifications.(Aseptic areas & Microbiology lab)

Training to the staff and operators.( regarding C GMP & Aseptic techniques)

Annual product review and reporting.

PQRA annually for each product.

Preparation and review SMF, VMP and MCP.

Cleaning validations and Disinfectants validations.

Washing machines qualifications and validations.

Review of BMR, Responsible for finished product release.

Conducting internal audits. (Inter, intra and Management review)

Implementation and Review of document control systems in the plant and Associated

with RA for dossier submissions.

Keywords: Validation, Qualification,CAPA, CGMP

Company Profile

An MNC Pharma Organisation
Contact Details
Company Name:
Impact HR Services Pvt.Ltd.
Executive Name:
Asifa Shaikh
Address:
Not Mentioned
Telephone:
022-42728916

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