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.
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 OrganisationContact Details
Company Name:
Impact HR Services Pvt.Ltd.
Website:
Executive Name:
Asifa Shaikh
Address:
Not Mentioned
Email Address:
Telephone:
022-42728916
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