Associate Manager - Quality Control - API

Job Description

Designation: Associate ManagerJob Location: BangaloreDepartment: Quality Control - APIAbout SyngeneIncorporated 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. 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.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.

Educational Qualification: M.Sc. Chemistry / M. PharmaTechnical/functional Skills:

• 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.

Experience: 12-14 Years of Industrial Experience in reputed Pharmaceutical Quality Control Department.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

Equal Opportunity Employer:It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
salescustomer relationsmisequal employment opportunityqualityanalytical method validationmanagementpharmaceutical quality control