Quality Assurance Analyst

Omega Plc; Dodworth; On-site; GBP 40,000 - 60,000; Full time

Job summary

A pharmaceutical company in Dodworth is seeking a GDP Quality Assurance professional to ensure compliance with regulations related to distribution and manufacturing practices. Responsibilities include releasing products to market, managing quality systems, and participating in audits. The ideal candidate has a Scientific University Degree and at least 5 years of relevant experience. This role offers competitive compensation and valuable career development opportunities.

Benefits

Competitive compensation

Career development opportunities

Inclusive work culture

Qualifications

• Minimum of 5 years’ experience in a GDP Quality Assurance Role.
• Good understanding of EU GDP/GMP regulations.
• Ability to maintain high-quality documentation.

Responsibilities

• Releases medicinal products to the market as an RPi delegate.
• Support quality systems on site, writing SOPs.
• Manage the Periodic Quality Review programme.

Skills

Quality Assurance

Good Distribution Practice (GDP)

Regulatory compliance

Documentation management

Risk management

Education

Scientific University Degree or equivalent

Tools

Trackwise

SAP

Job description

In this role you will be responsible for supporting GDP compliance of Omega Pharma Limited in accordance with the general conditions of the Wholesale Distribution Authorisation (WDA) and applicable current requirements of Good Distribution Practice (GDP). You will also support with GMP compliance of Omega Pharma Limited in accordance with the general Conditions of the Manufacturing and Import Authorisation (MIA) and applicable current requirements of Good Manufacturing Practice (GMP). Another key responsibility in this role will be to support quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements such as EU GDP Directive 2013/C 343/EU, Human Medicines Regulation 2012 and EU 2001/83/EU. It will also be your responsibility to act as an RPi delegate, releasing medicinal products to the market for OPL.

Scope of the Role

Responsibilities

• Releases medicinal products to the market for the OPL business as an RPi delegate. Ensuring product is safe for patients and any investigations are completed using risk‑based processes.
• Support quality systems on site such as raising Change Controls, Deviations, CAPAs as required and writing SOPs.
• Act as Quality Lead on business projects.
• Oversee routine and ad‑hoc rework processes, approve BOMs and manage FSDU/Display Pack Projects.
• Manage the Periodic Quality Review programme, preparing the OPL QA reviews and ensuring schedule adherence.
• Manage supplier and customer qualification and maintenance, including annual bona‑fide and monthly GMDP compliance checks.
• Participate in self‑inspections, internal and regulatory audits and ensure necessary corrective actions are put in place.

Qualifications

• Scientific University Degree or equivalent.
• Minimum of 5 years’ experience in a GDP Quality Assurance Role in the pharmaceutical industry.
• Good understanding of EU GDP/GMP.
• Ability to maintain high quality documentation, manage data sources and interpret data for key performance indicators to judge the operational state of processes.
• Work independently on QMS elements you are responsible for, knowing when to escalates appropriately any issues.
• Experience using electronic documentation systems, e.g., Trackwise, SAP.
• Comprehensive understanding of GMP, GDP, regulatory (UK Human Medicines, MHRA) and broader EU / PICS/ISO requirements for pharmaceuticals, cosmetics, biocides, food supplements & medical devices, together with direct experience dealing with regulatory agencies on quality and compliance matters.
• Thorough knowledge of technical and commercial requirements of the business associated with the quality units’ activities, role and resources; acts as a consulting expert in the quality field for complex issues related to quality, technical and regulatory requirements for the business, especially as they relate to GDP.

At Perrigo, we are driven by our mission to make lives better through trusted health and wellness solutions, accessible to all. We are proud to be a top‑10 player in the European consumer self‑care market and the largest U.S. store brand provider of over‑the‑counter and infant formula. Dedicated to providing the best self‑care for everyone, we are the people behind the brands you trust: Opill®, Compeed®, Solpadeine®, NiQuitin® and many more. We are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.