Micro- Quality Manager at Piramal Pharma Limited, Microbiology Candidates Apply Now

Micro- Quality Manager at Piramal Pharma Limited, Microbiology candidates Apply Now

Are you a highly experienced Quality professional with 10+ years in regulated pharmaceutical companies and a strong background in microbiology? Piramal Pharma Limited (PPL), a leading pharmaceutical company dedicated to providing high-quality healthcare solutions, is seeking a dedicated Manager – Quality (DDRC) – Micro to join our team in Mumbai. If you have expertise in Quality Management Systems, microbial data review, and a passion for ensuring regulatory compliance, we encourage you to apply! This is a full-time position.

Job Description

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)

Responsibilities of a Quality Manager

As a Manager – Quality (DDRC) – Micro at Piramal Pharma Limited, your responsibilities will include:

• Reviewing any microbial data generated in the microbiology laboratory.
• Reviewing microbiological and analytical data generated in labs, including entries in Open-Lab, lab notebooks, LIMS, and QMS modules.
• Ensuring accuracy and completeness in the review and generation of reports.
• Preparing and reviewing OOS, OOT, and lab incident investigations, ensuring thorough analysis and initiation of change controls.
• Reviewing planned and unplanned deviations for accuracy, completeness, and compliance with cGMP, data integrity, and written procedures.
• Reviewing protocols, reports, and Annual Product Quality Reviews (APQR).
• Collaborating with site teams to identify and address gaps during QMS event reviews and documentation.
• Coordinating with sites for review activities and planning to ensure efficient workflows.
• Engaging with customers and site teams to ensure timely closure of critical QMS events.
• Sharing review deficiencies with site teams for corrective actions.

Qualifications of a Quality Manager

QUALIFICATION: B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology

EXPERIENCE of a Quality Manager:

• 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.

Job Info

• Job Identification: 7811
• Posting Date: 04/15/2025, 03:11 PM
• Apply Before: 05/31/2025, 03:10 PM
• Degree Level: Bachelor’s Degree
• Job Schedule: Full-time
• Location: Project: Piramal Agastya

CLICK HERE TO APPLY ONLINE

Keywords: Manager Quality, Micro, Piramal Pharma Limited, Quality Management System, Microbiology, Regulatory Compliance, Pharmaceutical Industry, Quality Manager