Lead the analytical quality assurance for Sun Pharma Biologic product (Drug
substance, Drug Product & combination product as required).
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 as requried.
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 of inprocess, intermediates
and finished products. The QC Manager shall author scientifically sound deviation investigations and assessments and recommends effective corrective actions as appropriate.
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.
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 Senior QA Manager 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 the maintenance and update of quality management system related to analytical.
Support the timely implementation of global and local standards and procedures in the Sun China unit by execution of associated GAPs assessments against localprocedures where required.
Contribute to the interpretation of regulatory requirements in new or existing Biologics SOP′s.
Support for the regulatory queries related to analytical topics
Review & Approve the stability summary sheets.
Approval of documents related to quality.
Support technical,attendance & administrative requirement of team members.
Key Performance Indicators/result areas
On time preparation of CoA and on time batch release
In time management and closure of significant quality events, change controls, complaints, deviations etc.)
On time receipt and review of stability testing for each time point.Timely issuance of stability testing CoA.
On time assessment and implementation of Global procedures into QA
Biologic QMS.
On time submission of approved stability studies to Regulatory
authorities & others.
Manage attendance management and other administrative requirement for team members.
Education Qualifications (Graduate- Post Graduate)
Mandatory
? BSc in Bio chemistry/biotechnology of pharmaceutical field.
Preferred
? BSc. In biotechnology/biochemistry