QA Officer

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 also provide assistance to the Quality Assurance Department as required.

Principle Responsibilities

• Coordinating and maintaining all activities required for the disposition of drug substance by Qualified Persons.
• Responsible for the compliant maintenance of the Quality Management System.
• Constant reviewing Quality Management Systems (QMS) actions, Quality Events (QE), Corrective & Preventative Actions (CAPA), Change Controls etc.
• Responsible for the categorisation and review of QEs & CAPA plans, approval of CAPA actions.
• Responsible for the review and approval of Effectiveness checks (EC) and extension requests.
• Perform the review and approval of solution batch records (including PAS-X release).
• Review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of drug substance by Qualified Persons.
• Prepare any required corrective and preventative actions related to the release of drug substance.
• Liaise with external contractors and SERB personnel regarding the release of drug substance.
• To manage the release, transfer, shipment, quarantine and rejection procedures for drug substance.
• Perform release of cleaning, solution, bulk immunogens within production timelines.
• Conduct the product recall procedure as required.
• QA review of Validation documentation.
• Participation in the internal audit program.
• Perform customer enquiries and complaints procedure.
• To ensure key quality performance indicators are prepared and trended for the monthly report, management review and annual product reviews.
• Generation of Quality Council slides and monthly metric figure pulls for batch release and complaints.
• QA review/approval of controlled documents (SOP, WINs, FRMs etc).
• Support continuous improvement projects, (e.g. identify improvements, and support QMS/Operational Excellence (OpEx) improvements).
• Perform QA ‘Shop Floor’ activities as required by the QA department.
• Take opportunity as available to develop within areas of the Senior QA Officer & deputise for these roles.
• Support the release of drug product as required.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.
• Carry out other reasonable tasks as required by the Line Manager.

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 organised 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 capable with an ability to work with employees at all levels of seniority.

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. 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.