Qualified Person

7 months ago


Morpeth, United Kingdom Piramal Enterprises Full time

JOB OVERVIEW

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.

To act as “Qualified Person” for release of products to the market according to the Human Regulations Act and the Directive 2001/83/EC and 2001/20/EC and as named on the Piramal Manufacturer’s Licences.

**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

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 Pharma Solutions (PPS) **is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.



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