Assistant Manager – Quality Control Testing

Jobtailor; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Jobtailor in Bengaluru is seeking a qualified professional to support validation activities in a pharma manufacturing environment.

You will prepare and review process validation protocols, cleaning validation, and environmental monitoring reports, ensuring compliance with cGMP and ICH Q7. Experience with regulatory inspections (USFDA, TGA, MHRA) is valued, along with documentation support for BPCRs and GCRs.

Qualifications

• M.Sc. or M. Pharma required.
• To Follow cGMP
• Knowledge on ICH Q7
• Experience in regulatory inspections (USFDA, TGA, MHRA)

Responsibilities

• Prepare and validate process validation protocols.
• Prepare cleaning validation protocols and evaluation reports.
• Prepare trending reports for raw materials, intermediates and finished API.
• Perform re-evaluations, temperature mapping, and DM water validation.
• Review protocols and reports for equipment and support system qualification.
• Execute and monitor environmental monitoring programs.
• Review BPCRs/GCRs and manufacturing documentation support.

Skills

Process Validation

Cleaning Validation

Trending Report Preparation

Temperature Mapping

Equipment Change Control

DM Water Validation

Environmental Monitoring

Protocol Review

Manufacturing Documentation Support

Education

M.Sc.

M. Pharma

Job description

Responsibilities

• Preparation of Process validation protocol
• Cleaning validation protocol and cleaning evaluation report
• Preparation of Trending reports (Raw materials, Intermediates and Finished API)
• Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring
• Preparation, Review of protocols and reports for Equipment, Support system qualification
• Execution and monitoring of Environmental monitoring Programs
• Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support

Requirements

• M.Sc. / M. Pharma
• To Follow cGMP
• Knowledge on ICH Q7
• Experience in regulatory inspection like USFDA, TGA MHRA etc

Hard Skills

• Process Validation
• Cleaning Validation
• Trending Report Preparation
• Temperature Mapping
• Equipment Change Control
• DM Water Validation
• Environmental Monitoring
• Protocol Review
• Manufacturing Documentation Support

Certifications & Qualifications

• M.Sc.
• M. Pharma