Job Description: Quality Assurance Executive Pharmaceutical Formulation

Job Title

Quality Assurance Executive

Department

Quality Assurance (QA)

Location

Lactonova Nutripharm Pvt. Ltd, Mallapur, Hyderabad

Reports To

Quality Assurance Manager

Job Summary

The Quality Assurance Executive is responsible for ensuring that pharmaceutical formulation manufacturing activities comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. The role involves reviewing documentation, monitoring manufacturing processes, conducting investigations, supporting validation activities, and ensuring product quality throughout the manufacturing lifecycle.

Key Responsibilities

- Ensure compliance with c GMP, GLP, GDP, and regulatory guidelines (US FDA, WHO, EU GMP, MHRA, etc.).
- Formulation Certificate Preparation and Master Formula Record (MFR) preparation.
- Prepare and review the MFR based on the approved product formulation.
- Verify calculations for ingredient quantities and yields.
- Cross-check manufacturing instructions with validated processes.
- Ensure all in-process controls and acceptance criteria are included.
- Incorporate approved changes through the Change Control system.
- Issue controlled copies of the MFR to Production.
- Maintain revision history and document control.
- Archive superseded versions according to document retention procedures.
- Review and approve Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), SOPs, specifications, and protocols.
- Perform in-process quality assurance checks during manufacturing and packaging operations.
- Review artwork for accuracy before approval.
- Ensure manufacturing license number and company details are correct.
- Confirm batch number, manufacturing date, expiry date, and MRP printing area.
- Check storage conditions and warning statements, Verify barcode, QR code, and




- serialization (where applicable).
- Verify barcode, QR code, and serialization (where applicable).
- Ensure regulatory statements comply with market-specific requirements.
- Approve final artwork before printing.
- Control artwork revisions through the document control system.
- Conduct line clearance before production and packaging activities.
- Monitor environmental conditions and ensure compliance with cleanroom requirements.
- Investigate deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results.
- Coordinate and monitor Corrective and Preventive Actions (CAPA).
- Participate in change control management and risk assessment activities.
- Support qualification and validation activities (equipment, process, cleaning, and analytical validation).
- Perform internal audits and support regulatory and customer audits.
- Monitor product quality trends and recommend continuous improvement initiatives.
- Conduct GMP training for manufacturing personnel.
- Ensure compliance with data integrity requirements (ALCOA+ principles).
- Coordinate with Production, Quality Control, Warehouse, Engineering, and Regulatory Affairs departments to ensure quality compliance.

Required Qualifications

- Bachelor's or Master's degree in Pharmacy (B. Pharm/M.Pharm), Chemistry, Pharmaceutical Sciences, or a related life science discipline.
- 2–3 years of experience in Quality Assurance within a pharmaceutical formulation manufacturing facility.
- Experience with oral solids, injectables, sterile products, or topical formulations is preferred.





Required Skills

- Robust knowledge of cGMP, ICH guidelines, and pharmaceutical regulations.
- Experience in documentation review and quality systems. Master Formula Record (MFR) preparation and Art work.
- Knowledge of deviation, CAPA, change control, OOS, OOT, and risk management.
- Familiarity with validation and qualification activities.
- Good analytical and problem-solving skills.
- Strong communication and interpersonal skills.
- Proficiency in Microsoft Office applications.
- Ability to work independently and within cross-functional teams.

Preferred Knowledge

- US FDA, EU GMP, WHO GMP, PIC/S, and MHRA regulations.
- Data Integrity (ALCOA+) principles.
- Quality Risk Management (ICH Q9).
- Pharmaceutical Quality System (ICH Q10).
- Process Validation and Cleaning Validation.
- Audit preparedness and regulatory inspection support.

Key Competencies

- Attention to detail
- Documentation accuracy
- Regulatory compliance
- Decision-making
- Time management
- Teamwork
- Integrity and accountability
- Continuous improvement mindset

Working Conditions

- Pharmaceutical formulation manufacturing facility.
- Cleanroom and controlled environment operations.
- May require shift work based on production schedules.
- PPE compliance as per GMP requirements.

Performance Indicators (KPIs)

- GMP compliance rate
- Deviation closure within target timelines
- CAPA effectiveness
- Audit observations and compliance
- Documentation accuracy
- On-time batch disposition support
- Training compliance
- Regulatory inspection readiness

This JD is suitable for a Quality Assurance Executive in an oral solid dosage (OSD), sterile, or general pharmaceutical formulation manufacturing plant and aligns with industry expectations for FDA-, WHO-, and EU GMP-regulated facilities.

Mail: [email protected] , Mobile (phone hidden)

📌 Quality Assurance Executive (Hyderabad)
🏢 Lactonova Nutripharm
📍 Hyderabad