Manager -(QA Reviewer-QMS)
- G2 Healthcare Amara
- 10 to 14 Yrs
- Maharashtra
- 2 months ago
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Job Description
- JOBOVERVIEW:The role involves providing remote Quality Management System (QMS) support to Piramal Pharma Limited (PPL) sites, focusing on the management of OOS investigations, laboratory incidents, deviations, and change controls. Responsibilities include drafting and reviewing documentation, ensuring compliance with regulatory standards, and recommending continuous improvements. KEY STAKEHOLDERS: INTERNAL Site Quality Team (QC, QA), Corporate Functions EXTERNAL Regulators (during inspection), Solution Providers REPORTINGSTRUCTURE: PPL Site Quality (Functionally) & Central Quality-Document, Data Review & Creation(Admin) QUALIFICATION: B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology EXPERIENCE: Over 10 years of QC/QA experience in regulated pharmaceutical companies. Hands-on experience in reviewing OOS, OOT, and lab incident investigations, as well as carrying out investigations, initiating change controls, and managing deviations. Hands-on experience in reviewing of APQR. Strong knowledge of applicable regulatory requirements (USFDA, EU & Health Canada) Up-to-date awareness of the latest regulations and pharmacopeial standards. Proficient in Current Good Laboratory Practices (cGLP) and QC instrumentation. Demonstrated experience in coordinating with customers and site management teams for the closure of QMS. Excellent organizational skills with a focus on detail and commitment to quality. Strong verbal and written communication skills, with the ability to collaborate effectively within a team environment. Key Role & Responsibilities: Prepare and review OOS, OOT, and lab incident investigations, ensuring thorough analysis and initiation of change controls. Review all planned and unplanned deviations for accuracy, completeness, and compliance with cGMP, data integrity, and written procedures. Review of Protocol/Reports and APQR. Collaborate with site teams to address identified gaps during QMS event review and drafting. Engage with customers and site teams to ensure the timely closure of critical QMS events. Coordinate with the site for review activities and planning to ensure smooth workflows. Route documents through the Ensur application (or relevant platform) as needed across Piramal plants. Participate in customer audits and regulatory inspections, providing support to site teams. Lead and participate in additional tasks assigned by the Head of Department (HOD,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Manager -(QA Reviewer-QMS)Contact Details:
Company: Piramal PharmaLocation(s): Maharashtra+ View Contact
Keyskills: Deviations QC QA USFDA EU Collaboration Verbal
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G2 Healthcare Amara
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