Piramal Pharma Ltd
Website:
piramalpharma.com
Job details:
Be the First to Apply
Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Senior Manager - Quality, External Supply
Job Description
Responsible to ensure quality aspects of CMOs for Pharmaceutical and 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
Ensure the quality of products and processes by establishing and enforcing quality standards.
Business: Piramal Critical Care
Department: Quality
Location: Kurla
Travel: High
Key stakeholders
External: Statutory and Regulatory agencies, External Suppliers and contractors, Contract testing laboratories
Internal: CMO & Quality Head, CMO Quality team, Quality team, Central Quality team, Supply chain, Business development, Sales & marketing, Regulatory, PV, Artwork and others as required
Reporting structure
Reports to: CMO & Satellite Quality Head
Essential Qualifications
- Master’s Degree in Pharmacy or Chemistry, Microbiology. Advanced degrees are preferred, not mandated (Experience in Microbiology mandatory – act as SME)
Essential Experience
- Quality professional with about 10-15 years working experience in regulated Pharmaceutical Company in GMP environment.
- Hands on experience of quality systems in a GxP environment, and direct experience with USFDA and other health authority inspections.
- Well-organized and detailed oriented professional, with strong verbal and written comunication skills. Ability to priories the aspects critical for performance of operational business.
- A minimum of five (5) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products.
Roles And Responsibilities
- Having Knowledge of cGMPs and relevant GxPs and distribution processes
- Perform routine Quality audit of CMO and to take follow-up for timely closure of CAPA actions.
- Establish and apply quality standards in line with current regulatory requirements and other requirements of PCC management
- Ensure the implementation of the Company’s Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations at External Supply and satellite Quality.
- Lead/Support during meetings with external manufacturing organizations for discussion and status updates of current manufacturing, complaints and non-conformances.
- Ensure management of Internal and external change control by performing impact evaluation.
- Technical coordination with different functions within Piramal for faster resolution and approvals for complaints, change control, deviations and other investigations. Should be able to investigate / evaluate microbiology related events.
- Prepare and review quality documentation, including Quality Agreements.
- Management of non-conformance and complaint investigations at external sites, including initiation of tracking in internal systems,
- Support in management of change to specifications, processes, or procedures at external sites, including initiation of internal tracking documents, assignment of action items, and closure of projects.
- Provide final product disposition, including review of externally generated batch records and testing results.
- Management of stability program for externally manufactured product, including review of generated data.
- Review, and/or approval of Annual Product Quality Review documents for externally manufactured product. Provide support to Regulatory Affairs for Annual Reports.
- Perform internal audits and participate in Regulatory audit preparations. Support in CAPA preparation and ensure CAPAs are tracked to closure in timely manner.
- Review and approve artworks and ensure that only current artworks are used.
- Supplier review and approval, including planning, performing and documentation of audits, as well as tracking audit finding closure to completion.
- Provide support to CMO and Piramal functions like supply chain, technical operations and RA in process validation, API qualification activities etc.
- Provide support to Business development and sales team for launch of products in newer markets, by ensuring smooth flow of information from the CMO to the respective teams and ensuring all Quality related activities are complete.
- Represent QA in CMO related projects (Tech. Transfers) and provide inputs / guidance (specific to Microbiology) to project team with respect to quality related activities, review Tech Transfer documents (Protocols and reports).
- Support in activities related to CMO Quality operations like preparation of SOPs, document management etc., training and implementation of the same.
Click on Apply to know more.