Company Description
At TAPI, we're not just a companywe'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 peoplea 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
The Associate Director, Quality Control is responsible for leading and overseeing all Quality Control functions within the plant to ensure compliance with global regulatory requirements, cGMP standards, and internal quality systems. This role provides strategic and operational leadership for analytical laboratories, release testing, stability programs, method validation and transfer, and data integrity for APIs and intermediates. The Associate Director partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to support reliable product release, regulatory inspections, technology transfers, and continuous improvement initiatives, while fostering a strong culture of quality, compliance, and scientific excellence.
- Implementation of Procedure supporting the quality control SOP'S and Corporate SOP'S.
- Review and approval of specification of RM/FP/STP/SOP. Review and approval of Protocol/Reports.
- Ensuring and organizing Professional / regulatory training of QC Lab employees.
- Involving in the OOS and deviations from QC, QA and Production. Ensuring the investigation on OOT & boarder line results.
- Signing on approved column in data books, laboratory control card and signing on the COA of final material and signing on hard copies as well as approval (release) in LIMS.
- Implementing quality system with respect to regulatory ICH & CGMP requirement.
- Handling of customers queries and regulatory inspections. Supporting DMF'S w.r.t required documents from QC.
- Manpower evaluation in the lab as per Projections and allotment of jobs to team members timely. Monitoring of productivity of people and timeliness of Laboratory activities like releases and schedules.
- 24 7 audit readiness.
- Budget management of Capital and Revenue w.r.t QC as per the needs
- Ensuring the Annual maintenance and calibrations for all equipment in the QC Lab
- Ensuring software qualification and their CSV
- Ensuring the environmental, water samples analysis w.r.t chemical and microbiology as per schedules
- Ensuring all the analysis in laboratory including cleaning w.r.t production planning
- Gases (utilities) sampling and analysis as per requirement
- Ensuring standard /chemical reagent management and their qualification based on requirement
- Ensuring third party operation and their qualification
- Ensuring the Proper site transfers or method transfer to QC
- Ensuring method verification and validation based on requirement
- Facility up gradation w.r.t QC wherever required
- Supporting Corporate Quality Management as and when required
- Ensuring the implementation of Pharmacopeias updates.
Qualifications
- Education: M.Sc. in Chemistry.
- Experience: Minimum 18 years of industrial experience.
- Preferred Industries: API / Pharma.
- Good understanding of Quality control, Understanding of GXP
Additional Information
Make Your Mark with TAPI
Your journey with TAPI is more than a jobit'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. Apply on top of this page and our talent acquisition team will be in touch soon!
