Senior Manager Quality Control

TAPI; Gajraula; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

TAPI is seeking an experienced Quality Management professional to lead and oversee the Quality Management System in our laboratories. The role focuses on CAPA investigations, regulatory compliance, and seamless change control across lab operations.

You will supervise instrumentation, manage licensing and quality agreements, and drive audits, training, and data integrity across wet chemistry, stability, and microbiology functions to support API production and site KPIs.

Qualifications

• Experience with Quality Management Systems in laboratories.
• Extensive API industry experience.
• MSc in Chemistry is required.

Responsibilities

• Maintain and oversee the Quality Management System in laboratories, including investigations into lab errors and CAPAs.
• Monitor laboratory events (LIR and OOS) and KPIs to optimise cycle time and reduce incidents.
• Manage the change control process for laboratory operations per CCM procedures and regulatory requirements.
• Oversee qualification, calibration, and maintenance of laboratory instruments with proper documentation.
• Manage licensing, vendor agreements, and quality agreements to ensure compliance and partnerships.
• Supervise wet chemistry, stability, and microbiology teams to meet site KPIs.
• Conduct audit management activities and address observations and customer queries.
• Develop and deliver training programmes and maintain records with overdue training tracking.
• Promote a quality culture and data integrity awareness across the lab.
• Ensure local and global EHS KPIs, conduct GEMBA walks, and maintain trained emergency response across shifts.

Skills

Quality Management

CAPA

Regulatory Compliance

Lab Instrumentation

Documentation

Education

MSc in Chemistry

Tools

Laboratory Instruments

Calibration Procedures

Job description

At TAPI, were not just a companydwere a community committed to advancing health from the core. As the worlds leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, were shaping the future of health worldwide.
Our strength lies in our peopled a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Job Description

Job Responsibilities

• Maintain and oversee the Quality Management System in laboratories, including execution of investigations into laboratory errors and quality issues, determination of root causes, and implementation of appropriate CAPAs.
• Monitor laboratory events (LIR and OOS) and ensure compliance with relevant KPIs including cycle time optimisation, reduction in laboratory incidents, and minimisation of out-of-specification results due to laboratory error.
• Manage the change control process for laboratory operations, ensuring all modifications are governed through the appropriate CCM procedure and aligned with current pharmacopeial and regulatory requirements.
• Oversee qualification, calibration, and maintenance of laboratory instruments, minimising downtime whilst maintaining comprehensive documentation and records.
• Manage laboratory licensing, vendor agreements, and quality agreements to ensure effective operational partnerships and compliance.
• Supervise wet chemistry, stability, and microbiology teams to support timely analysis of finished products, intermediates, and raw materials whilst meeting site KPIs and business expectations.
• Conduct audit management activities, respond to audit observations and customer queries, and track compliance report completion for internal and external audits.
• Develop and deliver training programmes to ensure laboratory personnel are adequately qualified for their roles, maintain training records, and identify overdue or periodic training requirements.
• Promote a quality culture within the laboratory, establish data integrity awareness, and implement appropriate controls to prevent data integrity issues.
• Ensure compliance with local and global EHS KPIs, conduct safety-related GEMBA walks, and maintain availability of trained emergency response and first aid personnel across all shifts.

Qualifications

Experience Level:13-18 Years
Industry Experience: API Experience is required
Qualification:M.Sc. in Chemistry

Additional Information

Make Your Mark with TAPI

Your journey with TAPI is more than a job—its an opportunity to make a lasting impact on global health. If youre ready to lead, innovate, and inspire, were excited to welcome you to our team. Together, lets shape the future of pharmaceuticals.

Our Commitment

At TAPI, we believe great talent comes from many backgrounds and experiences. As an equal opportunity employer, we are committed to building a diverse, inclusive, and supportive workplace where everyone can belong, contribute, and grow. We encourage applications from all individuals who share our curiosity, ambition, and values.

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