Junior Manager – Quality Assurance

  Medical Writing

Job title: Junior Manager – Quality Assurance

Company: Syngene International Limited

Job description: Designation: Junior Manager-QA

Job Location: Bangalore

Department: Analytical Development – Early Phase GMP

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 involves in the analysis of Drug Substance/ Drug Product.

Job Description:

Key Responsibilities:

Responsibility Summary: * Responsible to review the Analytical documents (Raw Data/SOP) and ensure all the analytical activities are being followed as per the approved written procedures.

  • Ensure safety compliance as per Syngene policy and EHSS requirement.
  • Review of data generated with respect to its correctness, authenticity, completeness and other aspects of data integrity as per Data Integrity policy (Policy No. S/CQP/002) and S/QA/SOP/049 Data integrity .
  • Handling of QA activities related to S17 Early phase GMP Lab

Primary Responsibilities:

  • Review of analytical raw data generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification.
  • Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
  • Review of Outsourced analytical report
  • Review of logbooks with respect to all activity performed in the lab.
  • Responsible for taking any other job allocated by Department Head / Department In charge.
  • Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document
  • Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents.
  • Review the documents for completeness, compliance to Good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable
  • Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out
  • Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable
  • Responsible to ensure review and approval of analytical calibration reports and Review of method validation protocol and method transfer protocols.
  • Review of the test results in COA against specification along with other relevant sample information before approval.
  • In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory

Secondary Responsibilities:

  • Review of Specification, Standard Operating Procedure, Instrument Operating Procedure and Observation data sheet, Certificate of Analysis.
  • Responsible to ensure certificate of analysis are approved of Raw Material, Intermediate, In-process & Finished product.
  • Responsible to ensure Review & approval of working/Lab/impurity/GC standards/ thawing time of standards COA and reports.
  • Responsible to ensure release of raw material, packaging material, intermediate & finished product batches in LIMS.
  • Involving in investigation of Laboratory Incidence / OOS / OOT and ensuring investigation is performed as per procedure.
  • Responsible to ensure Quality Management system documents like change control, deviation, OOS, OOT, incidences are reviewed, approved & closed within the time period specified in respective SOP.
  • Ensuring of conducting regular GMP rounds at S17 Early phase GMP Laboratory.
  • Responsible to complete the training of a newly introduced or modified SOP s and IOP s in LMS.
  • Responsible to co-ordination and participation during regulatory audits, internal quality audits and vendor audits.
  • Responsible to ensure review of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of S17 Early phase GMP Lab.
  • Responsible to ensure review of laboratory incidence investigation report and closure
  • Issuance of Logbooks.
  • Any other responsibility as assigned by Head QA or his designee based on knowledge, experience and training.

Educational Qualification: M.Sc., M. Pharm, B.Sc.

Technical/functional Skills:

  • Should have Quality Control background.
  • Should have knowledge on Analytical Techniques.

Experience: 6 9 Years

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 strong in Data Integrity.
  • 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. ,

Other details

Expected salary:

Location: Bangalore, Karnataka

Job date: Thu, 06 Jan 2022 08:20:17 GMT

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