Quality Assurance Manager

Lactonova Nutripharm; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Lactonova Nutripharm is seeking a skilled Quality Assurance Manager to lead QA activities for pharmaceutical formulation manufacturing. The ideal candidate will oversee GMP, QMS, documentation, audits, validation, CAPA, deviations, change control, and regulatory compliance. Experience in nutraceuticals is a plus.

Qualification: B.Pharm / M.Pharm with 5–10 years of QA experience. Location: Mallapur, Hyderabad. Reporting to QA Head/MD.

Qualifications

• B.Pharm or M.Pharm with 5–10 years QA experience in pharma/formulations.

Responsibilities

• Establish, implement and maintain an effective Quality Management System (QMS).
• Oversee QA for manufacturing, packing and finished products.
• Review and approve batch records and other QA documents.
• Review deviations, investigations, CAPA, and change controls with root-cause analysis.
• Coordinate internal, customer, vendor, and regulatory audits.
• Ensure compliance with GMP/GLP/WHO-GMP and regulatory requirements.

Skills

GMP knowledge

Quality systems

Documentation

Deviations & CAPA

Change control

Audit management

Leadership

Cross-functional work

Education

B.Pharm

M.Pharm

Tools

QMS software

ERP systems

Job description

Job Description: Quality Assurance Manager

Position: Quality Assurance Manager
Industry: Pharmaceutical Formulations / Nutraceuticals
Experience: 510 Years
Qualification: B.Pharm / M.Pharm
Department: Quality Assurance
Location: Lactonova NuriNutripharm Pvt. Ltd, Mallapur, Hyderabad.
Reporting To: QA Head/ Managing Director

Job Summary

We are looking for an experienced and competent Quality Assurance Manager to lead and manage Quality Assurance activities for our pharmaceutical formulation manufacturing operations. The ideal candidate will have strong experience in GMP, Quality Management Systems, documentation, audits, validation, CAPA, deviations, change control, and regulatory compliance.

Experience in Nutraceutical manufacturing will be an added advantage.

Key Responsibilities

1. Quality Management System

• Establish, implement, and maintain an effective Quality Management System (QMS).
• Ensure compliance with applicable GMP, GLP, WHO-GMP, Schedule M, and regulatory requirements.
• Review and approve SOPs, specifications, protocols, reports, and other quality documents.
• Ensure effective implementation of Good Documentation Practices (GDP) and data integrity requirements.

2. Manufacturing & Batch Release

• Oversee QA activities related to manufacturing, packing, and finished products.
• Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and other batch documentation.
• Ensure timely review and release/rejection of finished products and raw materials as applicable.
• Monitor in-process controls and ensure adherence to approved procedures.

3. Deviations, CAPA & Change Control

• Review and approve deviations, investigations, root-cause analysis, CAPA, and change controls.
• Ensure effective implementation and closure of CAPA within defined timelines.
• Identify recurring quality issues and drive continuous improvement initiatives.

4. Validation & Qualification

• Review and approve validation and qualification protocols/reports.
• Ensure compliance with requirements related to process validation, cleaning validation, equipment qualification, analytical method validation, and computerized systems, as applicable.

5. Audits & Regulatory Compliance

• Coordinate and lead internal, customer, vendor, and regulatory audits.
• Ensure timely preparation of audit responses and effective closure of observations.
• Support regulatory inspections and ensure ongoing inspection readiness.
• Conduct vendor qualification and periodic evaluation where required.

6. Quality Risk Management

• Implement Quality Risk Management (QRM) principles across manufacturing and quality processes.
• Identify potential quality risks and develop appropriate mitigation plans.
• Monitor quality trends and establish preventive measures.

7. Training & Team Management

• Lead, mentor, and develop the QA team.
• Identify training requirements and ensure effective GMP and quality-related training.
• Promote a strong quality culture across the organization.
• Allocate responsibilities and monitor team performance.

8. Nutraceutical Quality - Preferred

• Knowledge of nutraceutical, dietary supplement, herbal, or health-product manufacturing will be an advantage.
• Familiarity with quality requirements related to nutraceutical raw materials, finished products, specifications, stability, documentation, and supplier qualification is preferred.

Required Skills & Competencies

• Strong knowledge of GMP and Pharmaceutical Quality Systems.
• Good understanding of pharmaceutical formulation manufacturing processes.
• Strong analytical, problem-solving, and investigation skills.
• Good knowledge of Deviation, CAPA, Change Control, OOS/OOT, Risk Assessment, and Audit Management.
• Excellent documentation and communication skills.
• Strong leadership and team-management capabilities.
• Ability to work cross-functionally with Production, QC, R&D, Regulatory Affairs, Engineering, and Supply Chain teams.
• Good computer skills and familiarity with QMS/ERP systems is preferred.

Eligibility

• Qualification: B.Pharm / M.Pharm
• Experience: 5–10 years in Quality Assurance within the pharmaceutical formulation industry.
• Experience in Nutraceuticals / Dietary Supplements will be preferred.
• Candidates with exposure to regulatory/customer audits and GMP implementation will be highly preferred.

Key Performance Indicators (KPIs)

• Timely batch documentation review and product release.
• Effective and timely closure of deviations, CAPA, and change controls.
• Audit readiness and closure of audit observations.
• Compliance with GMP and internal quality procedures.
• Reduction in recurring quality issues.
• Timely completion of validation and quality-system activities.
• Effective development and performance of the QA team.

Contact : [e-mail]/ Mobile: [phone]