Exciting Career Opportunity: Manager Quality (DDRC) at Piramal Pharma Solutions
Are you an experienced Quality professional looking for a dynamic role in the pharmaceutical industry? Piramal Pharma Solutions is seeking a Manager Quality (DDRC) to join its esteemed team in Mumbai, Maharashtra, India. This role is an excellent opportunity for professionals with strong analytical skills, regulatory expertise, and a commitment to quality.
Why Join Piramal Pharma Solutions?
With a legacy spanning over three decades, Piramal Group has established itself as a global leader in the pharmaceutical industry. With a strong foundation in ethics, innovation, and excellence, the company continues to expand its impact across the healthcare sector. As a part of this esteemed organization, you will have the opportunity to contribute to world-class pharmaceutical solutions while growing your career in a supportive and collaborative environment.
Job Overview
As a Manager Quality (DDRC) at Piramal Pharma Solutions, you will be responsible for providing remote support to PPL sites, reviewing analytical data, managing Laboratory Information Management Systems (LIMS), and ensuring compliance with quality management systems (QMS). The role involves collaborating with various internal and external stakeholders, regulatory authorities, and solution providers.
Key Responsibilities:
✔ LIMS Management: Preparation of Master Build in Lab Vantage or Labware LIMS. ✔ QMS Oversight: Managing Trackwise operations for QMS activities and compliance. ✔ Regulatory Compliance: Staying updated on USFDA, EU, Health Canada, and other regulatory requirements. ✔ Method Validation & Transfers: Preparation and review of Method Validation, Method Transfer, and Method Verification documents. ✔ Analytical Data Review: Reviewing analytical data, raw data, chromatography, and LIMS records for Raw Materials, Packaging Materials, and Finished Products. ✔ SOP Development: Preparing and reviewing Standard Operating Procedures (SOPs) and ensuring compliance with pharmacopeial requirements. ✔ Cross-functional Collaboration: Working closely with Site Quality Teams (QC & QA) and Corporate Functions. ✔ Regulatory Inspections: Engaging with regulators and ensuring audit readiness. ✔ Global Operations: Supporting multiple PPL sites across the US, Canada, and EU time zones, with travel opportunities (up to 3 months) for on-site quality assurance activities.
Who Can Apply?
Educational Qualifications:
✅ B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Microbiology degree.
Experience & Skills:
🔹 8+ years of experience in Quality Control (QC) / Quality Assurance (QA) within a regulated pharmaceutical environment. 🔹 Hands-on experience with laboratory software and analytical instruments (HPLC, GC, UV, IR, Dissolution, Malvern, KF Auto Titrator, etc). 🔹 Strong knowledge of LIMS for data entry, master build, and data review. 🔹 Familiarity with Trackwise, eDMS, and Ensure for document and quality system management. 🔹 Up-to-date knowledge of regulatory guidelines (USFDA, EU, Health Canada, etc). 🔹 Strong verbal and written communication skills with excellent team collaboration abilities. 🔹 Ability to manage data integrity, documentation, and compliance efficiently.
Why Work at Piramal?
Piramal Pharma Solutions offers a dynamic and growth-oriented work environment with ample opportunities for professional development. Employees are valued for their expertise and provided with the tools and resources necessary to excel in their careers.
💡 Competitive salary and benefits package 💡 Opportunities for career advancement 💡 Inclusive and diverse work culture 💡 Commitment to employee well-being and work-life balance
As an Equal Employment Opportunity (EEO) employer, Piramal Pharma Solutions is committed to fostering a diverse and inclusive workplace. The company provides equal opportunities regardless of race, gender, age, disability, or any other legally protected characteristic.
How to Apply?
If you are passionate about Quality Management and meet the qualifications, don’t miss this opportunity! Be the first to apply for this exciting role at Piramal Pharma Solutions in Mumbai.
📌 Apply Now & Take the Next Step in Your Pharma Career!