Role & responsibilities :

The General Manager Quality will hold single-point leadership of both Quality Assurance (QA) and Quality Control (QC) at the Sarigam site. The role is accountable for the Pharmaceutical Quality System (PQS), GMP compliance, laboratory excellence, product quality and timely batch disposition, and for keeping the site inspection-ready at all times.

Key Responsibilities

A. Quality System & Compliance

1. Lead the implementation, maintenance, and continual improvement of the Pharmaceutical Quality System (PQS) in line with applicable GMP requirements, the Quality Policy, regulatory guidelines, and approved quality standards.
2. Ensure effective implementation and control of quality systems, including SOPs, specifications, batch manufacturing records, batch packing records, protocols, quality manuals, and other GMP-related documentation.
3. Review and approve quality-related documents and reports, including deviations, change controls, CAPA, OOS/OOT investigations, risk assessments, validation protocols and reports, stability reports, APQR/PQR, batch records, and other quality system documents.
4. Ensure data integrity and good documentation practices across QA, QC, and manufacturing operations, in line with ALCOA+ principles.

B. Quality Assurance Operations

1. Oversee In-Process Quality Assurance (IPQA) activities and exercise the authority to initiate, monitor, suspend, or stop manufacturing operations based on quality risks, GMP compliance, and product quality requirements.
2. Ensure effective monitoring and control of manufacturing environments, plant hygiene, in-process quality checks, equipment qualification, process validation, cleaning validation, calibration, preventive maintenance, and other activities that may impact product quality.
3. Ensure the appropriate approval or rejection of starting materials, packaging materials, intermediates, bulk products, and finished products, and support the timely review and disposition of batches in accordance with approved procedures.

C. Quality Control Operations

1.



Lead all QC functions, including chemical, instrumental, microbiological, and stability testing of raw materials, packaging materials, in-process samples, intermediates, finished products, and water and environmental monitoring samples.
2. Ensure laboratory compliance with GLP and GMP requirements, including method validation and transfer, analytical instrument qualification and calibration, reference standard and working standard management, and control of reagents, columns, and volumetric solutions.
3. Ensure timely sampling, testing, and release of results so that batch release timelines and production schedules are met without compromising quality.
4. Oversee the stability program, including protocol design, chamber management, sample pull schedules, trending, and reporting, and ensure review of analytical data, audit trails, and chromatographic data to prevent data integrity lapses.
5. Oversee the microbiology laboratory, including environmental monitoring, water system monitoring, sterility and bioburden testing, and media and culture management, as applicable to the site.

D. Investigations & Risk Management

1. Lead investigations related to market complaints, product recalls, batch failures, OOS/OOT results, laboratory incidents, deviations, non-conformities, and quality events, and ensure timely implementation and effectiveness monitoring of corrective and preventive actions.
2. Drive quality risk management (QRM) practices across the site and ensure risk-based decision-making in quality and compliance matters.

E. Audits & Regulatory Readiness

1. Plan and conduct internal audits, self-inspections,



supplier and service-provider audits, and support regulatory, customer, and third-party audits while ensuring timely closure of audit observations and compliance commitments.
2. Act as the site's primary quality representative during regulatory and customer inspections, and maintain the site in a state of continuous inspection readiness.

F. People & Leadership

1. Develop and strengthen the QA and QC teams through manpower planning, technical and GMP training, performance management, coaching, succession planning, and capability development.
2. Ensure effective cross-functional coordination with Production, Engineering, R&D;, Regulatory Affairs, Supply Chain, and Corporate Quality teams.
3. Participate in Management Review Meetings and provide quality performance updates, compliance risks, quality metrics, improvement opportunities, and timely escalation of critical quality issues to senior management, to drive continual improvement and sustain a robust quality culture.

Preferred candidate profile :

Qualification

M.Pharm / B.Pharm / M.Sc. in Chemistry, Microbiology, or a relevant pharmaceutical science discipline.

Experience

1520 years of progressive experience in pharmaceutical manufacturing, with significant exposure to both Quality Assurance and Quality Control, including substantial experience in a leadership role. Prior experience facing regulatory inspections (such as USFDA, MHRA, EU GMP, WHO-GMP, or State/CDSCO authorities) is highly desirable.

Key Competencies

- GMP compliance and Pharmaceutical Quality System
- QA and QC functional leadership
- Laboratory management, method validation, and stability programs
- Data integrity and regulatory compliance
- Audit and inspection management
- Quality risk management
- Validation (process, cleaning, equipment, and analytical)
- Investigation management (deviations, OOS/OOT, CAPA)
- Team leadership and capability building
- Stakeholder management and solid decision-making skills

📌 General Manager Quality (QA & QC) (Vapi)
🏢 WOW Softech
📍 Vapi