Assistant Manager Quality Control-Biologics

  Medical Writing

Job title: Assistant Manager Quality Control-Biologics

Company: Sygene

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 Description

Key Responsibilities:

  • Responsible for the managing of all activities and ensuring the compliance related to Analytical section and consumables/calibration and preventive maintenance of instruments in Quality Control Biologics.
  • Planning and Allotment of work related to Analytical method validations and batch support activities.
  • Initiation and closure of Change control, Deviation, investigation, OOS and CAPA in Trackwise.
  • Review of documents pertaining to Method validations, batch release, instrument/equipment qualification, Calibration and Computer System Validation.
  • Closure of laboratory incidents related to Analytical 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 Analytical and biochemical section.
  • Gap analysis for new projects (Specification/Method of analysis etc.).
  • Coordination with cross function team for closure of CAPA related to Analytical and biochemical 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.
  • Telecon/ meetings related to projects and 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 Analytical and Biochemical sections.
  • Participating in internal/external audits and inventory management.
  • Writing audit response to internal/external audits related to Analytical and Biochemical 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 science

Experience: 10 12 years

Technical/functional Skills:

  • Planning and execution of analytical method validations, batch release analysis and shift schedule for manufacturing support.
  • 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, validation protocols and reports 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 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/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.

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Other details

Expected salary:

Location: Kolkata, West Bengal

Job date: Tue, 04 Jan 2022 08:29:50 GMT

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