Job Description

JOB OVERVIEW: The role entails providing remote support for the Quality Management System (QMS) and reviewing microbiology data for Piramal Pharma Limited (PPL) sites. Key responsibilities include overseeing Out of Specification (OOS) investigations, laboratory incidents, deviations, and change controls, as well as reviewing data generated in the microbiology laboratory. Additional duties involve drafting and reviewing documentation, ensuring adherence to regulatory standards, and recommending ongoing improvements.
KEY STAKEHOLDERS: INTERNAL – Site Quality Team (QC, QA), Corporate Functions
EXTERNAL – Regulators (during inspection), Solution Providers
REPORTING STRUCTURE: PPL Site Quality (Functionally) and CQA Document, Data Review & Creation
(Administratively)
•Review any microbial data generated in the microbiology•Review microbiological and analytical data generated in labs, including entries in Open-Lab, lab notebooks, LIMS, and QMS modules.•Ensure accuracy and completeness in the review and generation of reports.•Prepare and review OOS, OOT, and lab incident investigations, ensuring thorough analysis and initiation of change controls.• Review planned and unplanned deviations for accuracy, completeness, and compliance with cGMP, data integrity, and written procedures.•Review protocols, reports, and Annual Product Quality Reviews (APQR).•Collaborate with site teams to identify and address gaps during QMS event reviews and documentation.•Coordinate with sites for review activities and planning to ensure efficient workflows.•Engage with customers and site teams to ensure timely closure of critical QMS events.•Share review deficiencies with site teams for corrective actions.•Route documents through the Ensur application (or other relevant platforms) across Piramal plants.•Participate in customer audits and regulatory inspections, providing support to site teams.•Lead and participate in additional tasks or projects as assigned by the Head of Department (HOD).
QUALIFICATION: B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/MicrobiologyEXPERIENCE:•Need to be ready to live and embrace the Piramal values.•Quality professional with 10+ years of QC/QA experience in regulated pharmaceutical companies.•Hands-on experience reviewing microbial data generated in microbiology laboratories.•Skilled in reviewing OOS, OOT, and lab incident investigations, as well as initiating and managing deviations and change controls.•Experience in reviewing Annual Product Quality Reviews (APQR).•Strong knowledge of regulatory requirements including USFDA, EU, and Health Canada.•Proficient in current Good Laboratory Practices (cGLP) and use of QC instrumentation.•Demonstrated experience coordinating with customers and site management teams for effective QMS closure.•Well-organized, detail-oriented, and committed to maintaining high-quality standards.•Excellent verbal and written communication skills. effective team player with strong collaboration skills.