Junior Manager - QC

Job Description

Designation: Junior ManagerJob Location: BangaloreDepartment: Quality ControlAbout Syngene 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. 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.

• Must have analytical experience in GMP Quality Control (APIs & oral solid dosage forms) with reputed pharmaceutical company/CRO .
• Expertize in Instrument qualifications and computer system validation (CSV) as per 21 CFR part 11 and GAMP 5 requirement.
• Experience in handling of instrument calibration, preventive maintenance and instrument management activities.
• Experience in Laboratory compliance and audit trail reviews.
• Experience in LIMS, ELN, SAP, Chromeleon, Trackwise application softwares.
• 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 21 CFR Part 11 compliance environment and data integrity practices.
• Must have expertise in analytical troubleshooting in QC.
• 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 Instrument qualifications and computer system validation (CSV) as per 21 CFR part 11 and GAMP 5 requirement in GMP QC laboratory.
• Responsible for handling of instrument calibration, preventive maintenance and instrument management activities.
• Responsible for audit trail reviews and date & time verification of laboratory instrument softwares.
• Responsible for troubleshooting software issues in laboratory instruments and creation of reporting templates in instrument softwares.
• Responsible for handling of routine issues in LIMS, ELN, SAP, Chromeleon, Mass Hunter application softwares.
• To log change control and prepare documents related to instrument qualification.
• Risk assessment and SOP/ IOP preparations for new instrument installations or upgradations.
• Responsible for ensuring the samples are analyzed, reported within agreed SLA /TAT.
• Ensure that human errors in laboratory are monitored, reviewed, reduced and controlled within justifiable limits.
• Ensure that failures such as OOS, OOT, LIR and Deviations are adequately investigated, root cause identified and CAPA identified and implemented.
• 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.
• 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).

Educational Qualification: M.Sc. / M. Pharma (Analytical/General Chemistry)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), ELN, SAP, Chromeleon, EDMS, LMS, Trackwise application softwares.

Experience: 9-12 yearsBehavioral Skills:

• Strong commitment towards work and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to detail, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

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 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 :
commitment towards worksapcontinuous improvement facilitationcommissioningequal employment opportunityroot causetroubleshootingcomputer system validation21 cfrsafetymechanicalnew business generation