Assistant Manager

7-12 years

Not Disclosed

India

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Summary:

Role: Assistant Manager
Department: Quality Assurance
Location: Unit 1
Educational Qualification: [To be filled based on the specific requirement]
Experience Required: 7-12 years

Job Description:

Document Control:
- Review and approve SOPs, BMRs, and other quality documents.
- Check and review raw data and batch release data to ensure data integrity and correctness.
- Maintain soft copies of documents on the server.
Change Control, Deviation, and CAPA:
- Review Change Control, Deviations, and CAPAs.
Self-Inspection:
- Prepare inspection schedules.
- Execute audits according to the schedule.
- Prepare and close out inspection reports.
Vendor Qualification:
- Conduct vendor assessments and audits.
- Sign Quality Agreements with vendors.
Validation Activities:
- Assist in validation activities at the manufacturing site.
- Review qualification and validation documents.
Cell Bank Control:
- Oversee the receipt, storage, and documentation of cell banks.
GMP Compliance:
- Monitor current Good Manufacturing Practice (cGMP) compliance within the unit.
Authorization:
- Authorize QA documents as recommended by the Head of QA.
IPQA and Batch Release:
- Manage batch release processes.
- Review and ensure compliance with IPQA observations.
Market Complaints and Recalls:
- Handle market complaints, recalls, and returns.

Skills Required:

Batch Release
Shop Floor Investigation
PQR (Product Quality Review)
Batch Record Review

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Assistant Manager

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