Syngene looking for Quality Control Assistant Manager
Post : Assistant Manager – Quality Control – Biologics
Job Purpose :
This role will be leading the Raw Material & Packing Material Team activities in Quality Control Biologics lab.
• Responsible for the managing of all activities and ensuring the compliance related to Raw material/Packaging material/Process Consumables/calibration and preventive maintenance of instruments in Quality Control Biologics.
• Planning and Allotment of work related to RM and calibration team.
• Initiation and closure of Change control, Deviation, investigation, OOS and CAPA in Trackwise.
• Review of documents pertaining to instrument/equipment qualification, Calibration and Computer System Validation.
• Closure of laboratory incidents related to RM and calibration team.
• Review of specification/method of analysis/ODS in LIMS and EDMS.
• Approval of static data in LIMS.
• Preparation and revision of SOP’s related to RM and calibration team.
• Gap analysis for new projects (Specification/Method of analysis).
• Coordination with cross function team for closure of CAPA related to RM and calibration team.
• Responsible to complete all planned quality and compliance training as and when required by the department Head.
• Responsible to troubleshoot the problems, provide technical guidance, and mentor junior staff.
• Providing details and Supporting documents related to Regulatory requirements.
• Coordinating with SAP core team in resolving SAP related queries. Updating of the MIC and Inspection Plan for any RM/PM/Process consumables for biologics.
• Telecon/ meetings related to RM with project management/cross functional team.
• Review of all the compliance documents on monthly basis for the Equipment and instruments documents like calibration records/reports, logbooks related to RM and calibration team.
• Participating in internal/external audits and inventory management.
• Approval of purchase request related to Capex and general budget.
• Creation of reservation in SAP.
• Writing audit response to internal/external audits related to RM and Calibration team
• Coordination with cross function department and vendor to ensure smooth workflow in RM team and calibration team.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company.
• Masters in Chemistry (Any Masters in science)\
• Planning and execution of Raw materials, Process consumables and Packaging materials and verification of respective documents against monographs / vendor COA.
• Assistance in setup up of RMPM lab as per the direction of Supervisor/Section Head.
• Preparation of documentation such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product
• 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 details, 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 be a focused employee.
Job ID : 14844
Experience : 10 – 12 years
Qualification : MSc. Chemistry
Location : Bengaluru, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Control – Biologics
End Date : 30th October, 2020
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