QA Officer (Reviewer)

Renown Pharmaceuticals; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

Renown Pharmaceuticals is seeking a QA Officer (Reviewer) to ensure manufacturing, packing, testing, and release activities comply with Schedule M, cGMP, and ALCOA+ data integrity. The role reviews records, supports audits, and ensures only quality-approved materials and batches are released.

The candidate should have B.Pharm/M.Pharm/B.Sc/M.Sc (Chemistry) with 2–5 years in QA in pharma manufacturing, and be proficient in GMP, GDP, and regulatory requirements.

Qualifications

• Qualified in pharma with degree(s) in science or pharmacy.
• Experience in QA in pharmaceutical manufacturing.
• Knowledge of Schedule M, cGMP, and data integrity principles.

Responsibilities

• Review Batch Manufacturing Records (BMR) and BPR for completeness and compliance before batch release.
• Review in-process, finished product, and stability data against specifications; verify Certificates of Analysis (CoA).
• Verify release documentation for raw materials, packing materials, and finished goods.
• Review deviations, coordinate root cause analysis with departments, and ensure timely closure with CAPA.
• Review OOS/OOT investigations and verify closure per SOP.
• Review change control requests and assess quality impact before implementation.
• Handle market complaints, recalls, and returns including trend analysis.
• Draft, revise, and control SOPs and reports; maintain ERP master data accuracy (BOM, item codes).
• Plan and conduct internal audits and supplier/customer audits; train personnel on GMP and documentation.

Skills

QA/QC in pharma

Batch record review

cGMP

Data integrity (ALCOA+)

Audits & inspections

Root cause analysis & CAPA

Documentation control

ERP familiarity

MS Office

GDP/compliance

Education

B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry)

Tools

eQMS

SOP drafting

CoA verification

Job description

Department: Quality Assurance | Designation: QA Officer (Reviewer) |

Reports To: QA Manager / Head Quality Assurance |

Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry)

Job Purpose

To ensure that all manufacturing, packing, testing, and release activities comply with Schedule M, cGMP, and data integrity (ALCOA+) requirements. The QA Officer reviews records and investigations, controls documentation, supports audits, and makes sure that only quality-approved materials and batches are released to the market.

Key Responsibilities

1. Batch Record Review and Product Release

• Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for completeness and cGMP compliance before batch release.
• Review in-process, finished product, and stability data against approved specifications, and verify Certificates of Analysis (CoA).
• Verify release documentation for raw materials, packing materials, and finished goods, ensuring that only approved materials are used.

1. Quality Events and Investigations

• Review deviations, coordinate root cause analysis with concerned departments, and ensure timely closure with effective CAPA.
• Review Out of Specification (OOS) and Out of Trend (OOT) investigations and verify closure as per SOP.
• Review change control requests and assess quality impact before implementation.
• Handle market complaints, product recalls, and returns, including documentation and trend analysis.

1. Documentation and Document Control

• Review, draft, revise, and control SOPs, specifications, protocols, and reports as per the document control system.
• Maintain accuracy of ERP master data, including Bill of Materials (BOM) updates and item code assignment.

1. Validation, Qualification, and Calibration

• Review validation and qualification documents (IQ/OQ/PQ, process validation, cleaning validation) and confirm protocol compliance.
• Verify calibration, preventive maintenance, and cleaning records of equipment, instruments, and utilities.

1. Compliance, Audits, and Training

• Ensure compliance with Schedule M, cGMP, and data integrity principles (ALCOA+) in all paper and electronic records.
• Plan and conduct internal audits and self-inspections, and track observations to closure.
• Support regulatory and customer audits (WHO, US FDA, CDSCO) by preparing documents and facing inspections.
• Plan and conduct GMP training for personnel and maintain training records.

Key Skills

Technical Skills

Schedule M (revised), WHO-GMP, US FDA 21 CFR Parts 210/211, ICH Q7/Q9/Q10, CDSCO requirements

Regulatory knowledge

BMR/BPR review, CoA verification, SOP drafting, good documentation practices (GDP)

Documentation

Deviation, CAPA, OOS/OOT, change control, market complaints, recall handling

Quality systems

IQ/OQ/PQ, process validation, cleaning validation, calibration and PM review

Validation

ALCOA+, audit trail review, electronic record controls

Data integrity

Interpretation of in-process, finished product, and stability data

Analytical understanding

ERP (BOM, item codes), MS Office (Excel, Word), eQMS / document management systems

Systems

ERP (BOM, item codes), MS Office (Excel, Word), eQMS / document management systems

Behavioral and Soft Skills

• Strong attention to detail and a sharp eye for documentation errors
• Analytical and problem-solving ability, particularly for root cause analysis
• Clear written and verbal communication
• Cross-functional coordination with Production, QC, Engineering, Warehouse, and Regulatory Affairs
• Time management and the ability to meet batch release and CAPA timelines
• Integrity and a strong quality mindset
• Confidence in facing auditors and inspectors
• Training and presentation skills

Candidate Profile

Education

B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry)

Experience

2 to 5 years in Quality Assurance in a pharmaceutical manufacturing unit (freshers with strong academics and internship exposure may be considered for junior roles)

Industry exposure

Oral solid dosage / injectables / API (as applicable), with a regulated or WHO-GMP approved facility preferred

Audit exposure

Participation in at least one regulatory or customer audit (WHO, US FDA, CDSCO, etc.) preferred

Core competence

Hands-on BMR/BPR review, deviation/CAPA handling, change control, and SOP management

Computer proficiency

MS Office, ERP, and eQMS exposure

Personal attributes

Detail-oriented, ethical, disciplined, team player, able to work under deadlines

Location

As per company requirement; willingness to work in shifts if required

Desirable (Good to Have)

• Training in data integrity and Schedule M (revised) requirements
• Internal auditor or GMP lead auditor certification
• Experience in process validation and cleaning validation review
• Exposure to stability study data review

Key Performance Indicators (KPIs)

• Timely review and release of batch records (turnaround time)
• Percentage of deviations, CAPAs, and change controls closed within the defined timeline
• Number of documentation errors found after QA approval (right-first-time review)
• Completion of training and internal audit schedules as planned
• Audit readiness and closure of audit observations on time
• Accuracy of ERP master data (BOM and item codes)