To support the effective functioning of the Quality Management System and provide assistance to the Quality Assurance Department as required.
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 including review of Quality Management Systems (QMS) actions, Quality Events (QE), Corrective & Preventative Actions (CAPA), Change Controls (CC), 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 support 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.
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.
Qualifications
* 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.
* 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 with an ability to work with employees at all levels of seniority.
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