Lactonova Nutripharm Pvt. Ltd is hiring a Quality Assurance Executive for its pharmaceutical formulation facility at Mallapur, Hyderabad. This role is suitable for candidates with hands-on QA experience in a regulated formulation manufacturing environment and exposure to documentation, shop floor compliance, IPQA, MFR preparation, artwork review, validation support and quality systems.
The selected candidate will work within the Quality Assurance department and report to the Quality Assurance Manager. The position is aligned with formulation manufacturing operations such as oral solid dosage, sterile, injectables, topical or general pharmaceutical manufacturing facilities operating under GMP expectations.
Job Overview
| Position | Quality Assurance Executive |
| Department | Quality Assurance (QA) |
| Company | Lactonova Nutripharm Pvt. Ltd |
| Location | Mallapur, Hyderabad |
| Reporting To | Quality Assurance Manager |
| Experience | 2-3 years in Quality Assurance within a pharmaceutical formulation manufacturing facility |
Key Responsibilities
- Ensure compliance with cGMP, GLP, GDP and regulatory guidelines including US FDA, WHO, EU GMP and MHRA.
- Prepare formulation certificates and Master Formula Records.
- Prepare and review MFRs based on approved product formulation.
- Verify ingredient quantity calculations 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- Issue controlled copies of MFRs to Production and archive superseded versions as per document retention procedures.
- Maintain in-process checks and shop floor manufacturing process compliance.
- Review and approve Batch Manufacturing Records, Batch Packing Records, SOPs, specifications and protocols.
- Perform in-process quality assurance checks during manufacturing and packaging operations.
- Review artwork for accuracy before approval, including manufacturing licence number, company details, batch number, manufacturing date, expiry date, MRP printing area, storage conditions and warning statements.
- Verify barcode, QR code and serialization details where applicable.
- Ensure regulatory statements comply with market-specific requirements and 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 and Out-of-Trend results.
- Coordinate and monitor Corrective and Preventive Actions.
- Participate in change control management and risk assessment activities.
- Support qualification and validation activities including 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 based on ALCOA+ principles.
- Coordinate with Production, Quality Control, Warehouse, Engineering and Regulatory Affairs teams to ensure quality compliance.
Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences or a related life science discipline.
- B.Pharm or M.Pharm candidates are eligible as per the stated qualification requirement.
Experience Required
- 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 Knowledge and Skills
- Strong knowledge of cGMP, ICH guidelines and pharmaceutical regulations.
- Experience in documentation review and quality systems.
- Knowledge of Master Formula Record preparation, shop floor QA, IPQA and artwork review.
- 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 principles including ALCOA+.
- Quality Risk Management as per ICH Q9.
- Pharmaceutical Quality System as per ICH Q10.
- Process validation and cleaning validation.
- Audit preparedness and regulatory inspection support.
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.
How to Apply
Interested candidates can apply by sending their application to the HR email address provided below. Candidates may also contact the listed mobile number for application-related communication.
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Mobile: 6303037351
