Assistant Manager - Quality Control - Biologics Job in Syngene International

JOB DESCRIPTION

Designation: Assistant Manager

Job Location: Bangalore

Department: Quality Control-Biologics

About 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.

Job Purpose:

This role will be leading the Raw Material & Packing Material Team activities in Quality Control Biologics lab.

Job Description

Key Responsibilities:

• 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 SOPs 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.

Educational Qualification: Masters in Chemistry (Any Masters in science)

Experience: 10 12 years

Technical/functional Skills:

• 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

Behavioral 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 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.

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.