Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world.
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Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
Position: Asst General Manager – Quality Control
Location: Bangalore, Karnataka, India
- Must have experience in Quality Control (APIs & oral solid dosage forms) with reputed pharmaceutical company/CRO.
- Experience in handling of analytical method validation activities and reference standard qualification.
- Experience in handling of instrument calibration and instrument qualification activities.
- Knowledge in cGMP, ICH, USP, and other pharma regulatory guidelines.
- Interaction with client and project team for the smooth functioning of the projects.
- Must have experience in training the team members for GMP activities in QC.
- Must have experience in 21 CFR Part 11 compliance environment and data integrity practices.
- Must have experience in lab safety and personnel safety.
- Must have expertise in analytical troubleshooting in QC.
- Preparation of capital and revenue budget, manpower projection, and recruitment.
- Coordination with the instrument vendor and maintenance activities.
- Experience in handling of Laboratory incidents and deviations.
- Responsible for Quality Control operations and services and ensure compliance to Good Manufacturing Practices and other regulatory requirements.
- Responsible for ensuring the samples are analyzed, reported within agreed SLA /TAT.
- Leading a Quality Control (API/DP) Standard Qualification and Special Instrumentation Section.
- Ensure that human errors in the laboratory are monitored, reviewed, reduced and controlled within justifiable limits.
- Ensure that failures such as OOS, OOT, and LIR are adequately investigated, root cause identified and CAPA identified and implemented.
- Ensure that quality management system documentation is closed within the stipulated timelines mentioned in respective SOPs.
- Ensuring all members of Quality Control undergoes the required training and their knowledge and skills are updated to perform the duty efficiently.
- Ensure all equipment in the laboratory is functioning according to GMP requirements and is efficiently utilized.
- Interaction with QA, Production, R&D, regulatory and other departments for the functioning of QC lab.
- Interaction with the EHSS department for lab /personnel safety.
- Budgeting for the Quality Control Department.
- Recruitment of personnel to the Quality Control Department.
- Ensure regulatory surveillance needs are responded to in a timely manner and actions are taken to correct non-compliances.
- Ensure SOPs are written adequately and are complied with fully for each operation. Ensure no deviations between SOP and Practices.
- Knowledge of 21 FR part 11 compliance requirements, ICH, and FDA guidelines.
- Awareness about Data Integrity policies/procedures, lab safety, and personnel safety
- Experience in the handling of QMS (laboratory incidents, deviations, OOS, and OOT).
- Familiar with Chromatography and Non-Chromatography Analysis of Drug Substances and Drug Product.
- Well experienced in Analytical Techniques using scientific instruments like LCMS, ICP-MS, ICP-OES, TGA, DSC, GCMS, HPLC, GC, KFT, KFC, HPLC, GC, FTIR, UV, NMR, Polarimeter, KF/Auto Titrator, Coulometry, and Conventional Methods.
- Hands-on experience in LIMS (Labware), Chromeleon as an added advantage.
- Effective Communication Skills (Oral communication & presentation skills)
- Ability to influence people
- Motivational Skills
- Problem-Solving skills
- influencing skills
- Managing Conflict
- Team Leadership
- Interpersonal Skills
- Personal Integrity
Qualification: M.Sc Chemistry/M.Pharma
Experience: 20 years of Industrial Experience in reputed Pharmaceutical Quality Control Department.
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