To support the effective functioning of the Quality Management System and aid the Quality Assurance Department as required.
- Coordinating and maintaining all activities required for the disposition of finished product by Qualified Persons.
- Responsible for the compliant maintenance of the Quality Management System including review of QMS actions, QE’s, CAPA, CC’s etc.
- 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.
- Liaise with external contractors and personnel regarding the release of finished product.
- Prepare any required corrective and preventative actions related to the release of finished product.
- Generate Certificates of Analysis and statements of GMP Compliance.
- QA review of Validation documentation
- Participation in inspection readiness activities and the internal audit program
- To support the release, shipment, quarantine and rejection procedures for drug substance and finished product.
- To support the release, shipment, quarantine, and rejection procedures for drug substance within and finished product.
- Support the product recall procedure.
- Support release of cleaning, solution, bulk immunogens, and Drug Substance within production timelines.
- To support 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.
- Take opportunity as available to develop within areas of the QA Lead role and deputise for the QA Lead role as appropriate.
- 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 company values.
- Carry out other reasonable tasks as required by the Line Manager.
- 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.
Skills and Attributes
- 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.
- 25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
- Competitive Pension Scheme
- Private Medical Insurance
- Discretionary Bonus Plan
- Paid Maternity and Paternity Leave
- Academic Study Assistance
- Eyecare vouchers
- Employee Assistance Programme
Applications are encouraged from all sections of the community.