Manager- Integrated Quality & Compliance Lead (Injectable)

Piramal Pharma Solutions Inc.; Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Manager- Quality (DDRC) to lead integrated quality and compliance activities for injectable products. The role involves reviewing protocols and SOPs, supporting QMS, and ensuring regulatory compliance across QA functions.

The incumbent will perform risk assessments, manage supplier qualification lists, and provide SME QA support including night shifts, contributing to continuous quality improvements across the organization.

Responsibilities

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

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)

• Document Review & QMS Support: Review and approve protocols, SOPs, and provide support to the Quality Management System (QMS)
• SME QA Support: Provide subject matter expert (SME) QA support during night shifts
• Risk & Trend Analysis: Perform trend analysis and conduct risk assessments to support quality improvements
• Supplier Management: Manage and maintain the Approved Supplier List (ASL)
• Electronic Quality Systems: Provide support for electronic quality systems to ensure smooth operations and compliance

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.