Senior Manager, CMO Quality

Piramal Pharma Ltd•Bethlehem, PA

About The Position

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. 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. 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. 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 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. Provide support for new initiatives, imparting long-term quality strategy

Requirements

Knowledge of cGMPs and relevant GxPs and distribution processes

Responsibilities

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.
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.
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 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.
Provide support for new initiatives, imparting long-term quality strategy