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 Syngene International Ltd -opening for Quality Control Manager

 Syngene International Ltd -opening for Quality Control Manager

Post : Manager – Quality Control

Job Purpose : 
This role involves in Quality Control operations, services and ensure compliance to Good Manufacturing Practices and other regulatory requirements.   

Key Responsibilities
• 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 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 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 documentations are 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 are functioning according to GMP requirements and are efficiently utilized.
• Interaction with QA, Production, R&D, regulatory and other departments for the functioning of QC lab.
• Interaction with EHSS department for lab /personnel safety.
• Budgeting for 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 on 21 FR part 11 compliance requirement, 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).
• Possess the knowledge and exposure to environment, health, and safety (EHS) practices
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.

Candidate Profile
• M.Sc. Chemistry / M. Pharma
• Must have experience in Quality Control (APIs & oral solid dosage forms) with reputed pharmaceutical company/CRO.
• 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, HPLC, FTIR, UV, NMR, Polarimeter, KF/Auto Titrator, COulometry and Conventional Methods.
• Hands on experience in LIMS (Labware), Chromeleon as an added advantage.
• 15 plus Years of Industrial Experience in reputed Pharmaceutical Quality Control Department.
• 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

Additional Information
Job ID : 14861
Qualification : M.Sc. Chemistry / M. Pharma
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Control – API
End Date : 30th September, 2020


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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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