Sun Pharma Jobs – Biotech QA Manager Vacancy
Sun Pharma Jobs – Biotech QA Manager Vacancy. Sun Pharmaceutical Industries Ltd job openings. Quality Assurance Manager jobs for MSc biotechnology. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Manager – Quality Assurance
Date – May 5, 2022
Location – Bangalore – Plant
Company – Sun Pharmaceutical Industries Ltd
Job Description –
- Maintain oversight and management of stability studies executed by the testing labs, including preparation /review of stability protocols, raw data and review/preparation of reports while ensuring proper follow up at the testing site of timely execution of testing plans as per scheduled time points.
- Liaise with external Analytical testing lab for ensuring testing of GMP analytical samples in accordance with approved specifications while maintaining as well oversight of on-time testing and execution of stability sample testing.
- Skilled in troubleshooting and support in investigations.
- Perform timely review in accordance with the MA and with the approved analytical method of QC analytical data originated at the testing site and timely preparation and issuance of CoAs used for batch certification by the QP.
- Act as SME during evaluation and review of product-related change controls, deviations, out of specifications, complaints and analytical method validations in regards to analytical testing, and quality control of API, intermediates and finished products. The QA manager shall author scientifically sound deviation investigations and assessments and recommends effective corrective actions as appropriate.
- Creation, review and maintenance of testing analytical methods and specification ensuring compliance with validation studies and with the marketing authorizations while ensuring proper communication with the testing labs upon receipt or generation of change controls affecting approved analytical methods or relevant specifications.
- Preparation, review and assessment of routine trending of stability data collected for new and annual stability programs and ensuring immediate notification to the QP in case of observed trends or suspected out of specifications.
- Support/author analytical technical assessment as required for supporting deviation investigation or other relevant studies.
- Support with preparation of PQR/APR from a QC perspective in regards to continuous analytical trending and assessment of analytical data.
- Support the maintenance and update of the QA/QC B&CM quality management system.
- Support the timely implementation of global standards and procedures in the B&CM units by execution of associated GAPs assessments against local procedures.
- Act as initiator and reviewer of local standards to ensure timely and appropriate review and approval of controlled documentation part of the B&CM QMS EU.
- Contribute to the interpretation of regulatory requirements in new or existing B&CM SOPs.
- Prepare, review and /or approve the stability summary sheets.
Education Qualifications (Graduate- Post Graduate)
Mandatory
- MSc in chemistry/biotechnology of pharmaceutical field.
Work experience
Mandatory
- Minimum 6 years of experience in quality control, analytical research and development, and (bio) analytical methods qualification.
- Direct experience with Bioanalytical/bioassays tests, analytical (e.g HPLC) tests, extended characterization and microbiological testing.
- Knowledge and understanding of cGMP regulations and good documentation and laboratory practices.
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