QP

Piramal Pharma Solutions is a leading global CDMO of advanced drug development and manufacturing solutions to the pharmaceutical industry.

To act as the key contact point for all QA and GMP issues on the Morpeth Site, for products imported into or manufactured on behalf of the Morpeth Site.

1. Responsibilities and Key Tasks

QP specific activities

•Act as QP for all products manufactured and packaged at the Morpeth site

•To ensure product is made in accordance with manufacturing licences and equivalent marketing authorizations

•Assure product, process and facilities comply with national and global regulatory requirements in alignment to the Morpeth site policies

•Provide quality oversight of all activities on site and of subcontractors

•To actively participate in/chair Site Quality Review Team Meetings

•To ensure any significant quality or compliance issues are escalated to senior management

•To review and approve quality documentation

•To conduct internal audits and advise on corrective action

•To conduct external audits of supplies vendors, contractors and service providers

•Provide support for customer visits and audits

•Provides pro-active support for and initiates quality improvements within Manufacturing and Quality

•Deliver training

Critical Tasks

•Provide QA support to manufacturing, packaging and supply chain, and to all business areas

•Provide advice, guidance, support and mentoring to all staff with the Morpeth site in matters relating to the safety, quality and efficacy of the manufacturing and distribution of medicinal products and investigational medical products

•Participate as a member of the site Quality Management Review Team

•Review, assess and management of quality risk

•Drive Continuous improvement

•Champion Quality Agenda

Good Manufacturing Practice - GMP

Piramal Healthcare UK Ltd have a responsibility to manufacture medicinal products of the requisite quality, fit for their intended use and be in accordance with the relevant Manufacturing and Marketing Authorisations, Clinical Trial Authorisation, Product Specification, Drug Master File or CEP Dossier as appropriate and which do not place patients at risk due to inadequate safety, quality or efficacy. The Pharmaceutical Quality System, which incorporates Good Manufacturing Practice, is designed to deliver this quality objective, the attainment of which requires the participation and commitment of all staff across departments and at all levels within the company.

Good Manufacturing Practice is the part of Quality Management which ensures that products are consistently produced to the correct quality standards. To comply with the principles of GMP, it is required that clearly defined procedures are adhered to when performing operations across the site.

Health and Safety

As an employer Piramal is responsible for conducting its activities in line with its legal obligations under the Health and Safety at Work Act 1974. It is Piramal’s expectation that all employees observe their individual legal duties under the Act in so far as taking reasonable care of themselves and others who may be affected by their acts or omissions at work, and to cooperate with those persons appointed at Piramal to ensure that any relevant statutory duties are complied with.

It is Piramal’s expectation that all employees are actively engaged in matters related to Health, Safety and Environmental protection and that risk control measures are continuously reviewed and adhered to.