Manager- Integrated Quality & Compliance Lead (Injectable)

Piramal Pharma Ltd; Mumbai; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Piramal Pharma Solutions in Mumbai invites applications for a Manager- Quality (DDRC) to oversee QA activities across injectable programs. You will review protocols, SOPs, and support QMS, acting as SME QA during night shifts to ensure compliance.

The role emphasizes risk and trend analysis, supplier management through the ASL, and managing electronic quality systems to maintain product integrity and regulatory readiness.

Qualifications

• Experience in QA/QMS for injectables.
• Knowledge of GMP and regulatory expectations.
• Strong risk assessment and supplier management skills.

Responsibilities

• Review and approve protocols, SOPs, and support the QMS.
• Provide SME QA support during night shifts.
• Perform trend analysis and risk assessments for quality improvements.
• Manage and maintain the Approved Supplier List (ASL).
• Support electronic quality systems to ensure compliance.

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manager- Quality (DDRC)

Job Description

Integrated Quality & Compliance Lead (Injectable)

1. Document Review & QMS Support:

• Review and approve protocols, SOPs, and provide support to the Quality Management System (QMS)

1. SME QA Support:

• Provide subject matter expert (SME) QA support during night shifts

1. Risk & Trend Analysis:

• Perform trend analysis and conduct risk assessments to support quality improvements

1. Supplier Management:

• Manage and maintain the Approved Supplier List (ASL)

1. Electronic Quality Systems:

• Provide support for electronic quality systems to ensure smooth operations and compliance