Pharmaceutical Quality Assurance Specialist (12-month maternity cover)
Hemel Hempstead/Hybrid (up to 3 days a week from home)
£competitive + benefits
At GAMA Healthcare we help prevent infections and save lives. Our product portfolio ranges from disinfectant wipes and hand gels (Clinell), medical equipment (rediroom) to our pharmaceutical product Hexi Prep. As infection prevention has become a global priority, the demand has increased for our innovative, reliable products across new industries and new countries.
As the Quality Assurance Specialist, you will be responsible for managing our Pharmaceutical Quality Management Systems (QMS) and all related activities, making sure deadlines are met.
Reporting to our Head of Quality, we're looking for someone who is highly organised with an excellent working knowledge of Good Distribution Practice (GDP) and Pharmacovigilance.
What will you do?
- Maintain the QMS inline with Good Distribution Practice (GDP), GdocP and GvPv requirements
- Conduct regular internal GDP audits and support external audits
- Be responsible for Corrective and Preventative Action (CAPA), deviations, change controls and quality risk assessments ensuring actions are completed on time
- Create and update Standard Operating Procedures (SOP) and controlled documents
- Build and maintain awareness of the QMS requirements throughout the business
- Conduct and support external audits for Manufacturer (GMP) and Distribution (GDP)
- Assist in the investigation of customer complaints
- Manage external stakeholders e.g. to monitor and control trends in stability studies results
- Qualify and approve new customers and/or suppliers in collaboration with our Responsible Person
What will you need to be successful?
- Demonstrable success in a pharmaceutical QA role, with experience managing all QMS activities is essential
- Internal or lead GDP auditor qualification
- Knowledge of Pharmacovigilance, Stability Studies and GMP is highly desirable
- Relevant scientific degree e.g. Chemistry or equivalent
- Great communication skills as you'll be working with a range of internal and external stakeholders
- Proficient in Excel (intermediate and above)
- Excellent organisational skills with the ability to prioritise multiple, competing responsibilities
- Live GAMA's values: be passionate; win together; care; be curious and innovative; have fun!
What will you get when you join GAMA?
- A competitive salary and pension scheme
- Commitment to your personal and professional development
- 34 days holiday (including bank holidays)
- Discounted gym memberships
- Private Medical Insurance
- Health Cashback plan for vouchers toward opticians, physio, dental etc
What is it like at GAMA?
At GAMA Healthcare we are motivated by purpose, not just the potential of our brands. We are an innovative company led by two inspiring entrepreneur doctors. The pace is fast and, when needed, we can shift direction quickly, but we pull together to get things done.
We are proud of our people, and you will always have the support and encouragement needed to be successful. For several years we have achieved double digit growth and we are not stopping there.
GAMA promotes equality of opportunity for all as part of our inclusive culture.
We are looking for capable people to join us on our journey