QA Officer

Quality HR Services

2 - 5 years

2 - 4 Lacs

vapi

Posted:1 day ago| Platform:

Apply

Skills Required

fda gmp ich quality systems regulatory guidelines capa quality control data validation production bpr bmr documentation auditing audit report internal audit change control qc sop quality assurance cleaning validation batch manufacturing apqr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Documentation & Record Review:
Review specifications, sampling instructions, test methods, and analytical reports.
Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records.
Review completed Batch Production Records and Laboratory Control Records post-batch completion.
Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports.
Review and finalize Certificate of Analysis (CoA) for finished products.
Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports.
Review Standard Operating Procedures (SOPs) and Annual Product Quality Review (APQR) reports.
Batch Release & Plant Compliance:
Responsible for batch release in accordance with company SOPs and regulatory requirements.
Perform regular plant rounds and monitor daily compliance in production, QC, and warehouse areas.
Ensure finished goods dispatch is in line with quality requirements.
Validation & Qualification:
Preparation, execution, and review of Cleaning Validation Protocols and Reports.
Preparation of Clean and Dirty Equipment Hold Time Study Reports.
Conduct Campaign Cleaning Validation and monitor validation batches.
Review of Validation Protocols/Reports and Equipment Qualification Protocols/Reports.
Toxicology Data collection and PDE (Permitted Daily Exposure) value calculations.
Audit & Regulatory Compliance:
Plan and execute Internal Audits as per defined schedules.
Ensure closure of audit observations through CAPA management.
Handle deviations, change controls, and market complaints in coordination with relevant departments.
Liaison with external auditors and regulatory bodies during audits/inspections.
Cross-functional Coordination:
Coordinate with Production, Quality Control, Engineering, and Warehouse departments for validation and quality-related activities.
Support validation and qualification activities during product scale-up or technology transfer.

Required Skills:

Strong understanding of GMP, ICH, FDA, and regulatory guidelines.
Documentation accuracy and attention to detail.
Strong interpersonal and communication skills.
Proficient in handling Quality Systems (Deviations, CAPA, Change Control).

Required Qualification

B.Sc/M.Sc/B.Pharm/M.Pharm - Chemistry

More Jobs at Quality HR Services

Civil Manager

cuddalore, tamil nadu

12.0 - 16.0 yrs

Salary: Not disclosed

Chemist/Executive - QC (Mundra)

bhuj

5.0 - 10.0 yrs

INR 5 - 10 Lacs

Production Manager

vapi

8.0 - 10.0 yrs

INR 5 - 9 Lacs

Maintenance Fitter

vapi

2.0 - 4.0 yrs

INR 1 - 3 Lacs

HR Coordinator

vapi

Experience: Not specified

INR 2 - 5 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.