Senior Manager Quality Control

TAPI; Amroha; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

TAPI, a leading pharma API supplier, seeks a seasoned Quality Assurance leader to manage the laboratory Quality Management System and drive CAPA programs. The role focuses on investigations, root-cause analysis, and maintaining regulatory compliance across QC functions.

Ideal candidates hold 13–18 years of API quality experience, with an MSc in Chemistry, and demonstrated leadership in audits, training, and data integrity. On-site in India.

Qualifications

• Experience leading quality management systems in laboratories.
• Ability to investigate laboratory errors and implement CAPAs.
• Strong knowledge of KPIs, audits, and GMP/compliance.

Responsibilities

• Maintain and oversee the Quality Management System in laboratories.
• Investigate laboratory errors, determine root causes, implement CAPAs.
• Monitor KPIs like cycle time, lab incidents, and out-of-spec results.
• Manage change control for lab operations per CCM procedures.
• Oversee qualification, calibration, and maintenance of instruments.
• Manage licensing, vendor agreements, and quality agreements.
• Supervise wet chemistry, stability, and microbiology teams.
• Conduct audit management, respond to observations and inquiries.
• Deliver training programs and maintain training records.
• Promote data integrity and safety across shifts.

Skills

Quality management

Investigations

Leadership

Analytical thinking

Education

M.Sc. in Chemistry

Job description

Company Description

At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s 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, we’re shaping the future of health worldwide.

Our strength lies in our people—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

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s 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.