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

Job Description:

Job Purpose:

  • 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.

Key Responsibilities:

  • 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).

Technical/Functional Skills:

  • 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.

Behavioral Skills:

  • Effective Communication Skills (Oral communication & presentation skills)
  • Ability to influence people
  • Adaptability/Flexibility
  • 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.

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

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