Senior Quality

2 months ago


Barnsley, United Kingdom Perrigo Full time

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.

**Description Overview**:
The Quality Assurance Associate is responsible for ensuring GMP compliance of the Galpharm International and Omega Pharma Limited organisations and activities with the general conditions of the Manufacturing & Import Authorisation (MIA) and Marketing Authorisations (MA).

**Scope of the Role**:
**Responsibilities**:

- Responsible for day-to-day GMP/MAH activities.
- Manage quality systems on site for Supplier Management, Annual Product Quality Reviews and Stability.
- Maintenance of GMP and Marketing Authorisation Holder responsibilities Technical Agreements
- Management of Stability Study Requirements, including setting up protocols, dealing with method transfers and analysing reports
- Responsible for data analysis and reviews of product quality reports to ensure products and processes remain in a state of control.
- Support QPs in EU GMP Annex 16 requirements
- Act as Quality Subject Matter Expert on projects including working as part of a multidisciplinary team as required.
- Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.
- Support the monthly metrics meetings
- Flexibility to take on additional tasks and responsibilities at the discretion of the QA Manager.

**Experience Required**:

- Minimum of 3-5 years’ experience in GDP/GMP environment or quality role in a pharmaceutical setting.
- Ideally experience working in a QA team/environment
- Self-motived to deliver against objectives and ensure completion of activities.
- Experience in the use of root cause analysis and CAPAs in the investigation and resolution of deviations.
- Demonstrates good knowledge of ICH, EU and MHRA GDP/GMP regulations
- Knowledge of Cosmetics, Biocides or Medical Devices is advantageous.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better. #DIV



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