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.
Bachelor s Degree required with focus in Pharmacy, Chemistry, or Microbiology. Master s degree preferred
