Job Description

Business: Piramal Critical Care


Department: Quality


Location: Kurla, Mumbai


Travel: Medium





Job Overview: Responsible for managing quality aspects of all products distributed to U.S. and support all CMOs located within the geography. Act as point of contact between CMO an Piramal to ensure that the operational business is in compliance with cGMP, the Quality Technical Agreement, regulatory requirements, Piramal Quality Manual and established SOPs. Ensure CMO Quality Operations are conducted in accordance with Piramal core values and ethical practices





Key Stakeholders: Internal: • CMO Quality team
• Quality team
• Central Quality
• Supply chain, Business development, Sales & marketing, Regulatory, PV, Artwork and others as required

Key Stakeholders: External • ES team at the factory
• Statutory and Regulatory agencies
• External Suppliers and contractors
• Contract testing laboratories



Reporting Structure: Sr. Manager - ESQ US & Chief Manger - ESQ India


Experience: • Quality professional with minimum 8-10 years working experience in regulated pharmaceutical companies in GMP environment that use contract manufacturers.
• Having Knowledge of cGMPs and relevant GxPs and distribution processes.
• Hands on experience of quality systems in a GxP environment.
• Direct experience with FDA required; knowledge of EU GMP, MHRA, and other health authorities preferred.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills. Ability to priories the aspects critical for performance of operational business.
• Pleasing personality, with good adaptability to the surroundings and ability to collaborate with cross functional teams

Competencies: • Driving action driven activities to serve internal Customers
• Builds contingency plans to deal with setbacks.
• Takes ownership of functional/department goals
• Understands group dynamics to build collaborative teams.
• Encourages collaboration by linking team and business goals.
• Builds networks across boundaries with business, government and other stakeholders

Key Role & Responsibilities:

• Provides quality and compliance oversight in the area of QA /QC support at CMOs ensuring a secure supply of high-quality products. Escalates issues to management.
• Supports implementation of QMS requirements per regulatory and Piramal requirements at CMOs and confirms that product is getting manufactured at the site per cGMP requirements.
• Provides support in the area of regulatory compliance at CMO to ensure no disruption to supply and no regulatory punitive action.
• Perform release of finished products ensuring quick resolution of quality related issues.
• Provides QA oversight and confirms adequate GMP compliance at the CMO sites for new and current products including process validation, master documentation approval and the implementation of quality agreements.
• Performs routine audits of CMOs, follow-up for CAPA actions and tracks to closure and maintenance of an updated audit schedule.
• Supports CMOs in response to regulatory queries and deficiencies as required.
• Conducts supplier reviews and approvals including planning, performing and documentation of audits as well as tracking audit-finding closure to completion.
• Support QP for required documentation including documentation for batch release in EU/UK.
• Authors, reviews and/or approves change controls, deviations and other QMS documents raised internally or at CMOs.
• Manages customer complaints at external sites including initiation of internal tracking documents, assignment of action items and complaint resolution.
• Reviewing, and/or approving Annual Product Quality Review documents for externally manufactured products. Supports Regulatory affairs for annual reports, regulatory filings and variations and filing of FARs where required.
• Management of stability program for externally manufactured products, including review of generated data.
• Review and approve artworks and ensure that only current artworks are used.
• Supports management review meetings within Piramal for CMOs under scope and reports KPIs to management monthly.
• Handles and escalates to management quality issues related to raw and packaging materials, review and approve destruction of materials, coordination with supply chain and other teams within Piramal
• Meets with external manufacturing organizations as required for discussion and status updates of current manufacturing, complaints and non-conformances.
• Provide support to CMO and Piramal functions like supply chain, technical operations and RA in process validation, API qualification activities etc..
• Participation in due diligence data review (as and when required)
• Represent QA in CMO related projects (Tech. Transfers) and provide inputs / guidance to project team with respect to quality related activities, review and approve Tech Transfer documents (Protocols and reports).
• Supports activities related to CMO Quality operations like preparation of SOPs, Quality road map, document management, training and new initiatives
• Any other activity as required by Reporting Manager.


In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.



Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.



We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.


PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.


Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.


Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.