QA Officer
Wales
Come and Save Lives with Us!
SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies.
For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes.
Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.
Having the right culture is as important to us as having the right portfolio. We are guided by our four values:
- We make patients our priority
- We act with accountability and integrity
- We work together as one team
- We look for better ways forward
By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.
Broad Function
To support the effective functioning of the Quality Management System and batch release and provide assistance to the Quality Assurance Department as required.
Principle Responsibilities
1. Coordinating and maintaining all activities required for the disposition of finished product by Qualified Persons.
2. Responsible for the compliant maintenance of the Quality Management System including review of QMS actions, QE’s, CAPA, CC’s etc.
3. Review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of finished product by Qualified Persons.
4. Liaise with external contractors and Serb personnel regarding the release of finished product.
5. Prepare any required corrective and preventative actions related to the release of finished product.
6. Generate Certificates of Analysis and statements of GMP Compliance.
7. QA review of Validation documentation
8. Participation in inspection readiness activities and the internal audit program
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Education and Experience
• Educated to degree level or equivalent in appropriate scientific discipline such as Chemistry, Biochemistry, Microbiology or life sciences (An applicable level of related industry experience in lieu of a degree will be considered)
• Previous experience of working within the pharmaceutical industry is desirable, preferably with experience in GMP and Quality Assurance roles
• Computer literacy (including word, power point, excel, databases)
• Experience of working with a regulated industry
Skills and Attributes
• Competent and highly organise individual who has a keen eye for detail
• Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues
• Ability to prioritise and execute tasks in a high pressure environment
• Strong written and oral communication skills
• Excellent organisational skills and the ability to work to tight deadlines within a team environment
• Self-motivated and directed
• Confident and with an ability to work with employees at all levels of seniority.
Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.