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Quality Assurance Officer (Capital Works)


An exciting opportunity has arisen for a Permanent Quality Assurance Officer (Capital Works) to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities.Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals. We develop new vaccines, therapeutic proteins and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

The Quality Assurance Officer (Capital Works) will be in receipt of a competitive benefits package, including:

* 30 days of holiday, plus 8 bank holidays;

* On the job training, and genuine opportunities for growth and advancement;

* Generous pension scheme;

* Access to online discounts;

* A work environment based in the beautiful Salisbury countryside, with free on-site parking; easy access to London and the south coast

* Onsite canteen.

* Onsite nursery

The successful candidate will be joining the Quality Assurance Department, who are responsible for the management of the non-conformance and CAPA systems to support the manufacturing and testing of pharmaceutical products to GMP, the management of change control and risk management systems, the management for the internal and supplier audit management programmes, the management of the product review process the management of QA environmental compliance and the provision of QA oversight of manufacturing and testing activities. As a Quality Assurance Officer (Capital Works) for Porton Biopharma, the post holder will support Capital Works and other projects across multiple departments within PBL, ensuring that all activities are compliant and that required reviews are completed in a timely manner. In addition, the post holder will provide support to departmental In Process Teams (IPT) by performing all duties associated with the release of pharmaceutical products.

*Key responsibilities:*

* To support the co-ordination and planning of project workload, ensuring Quality matters are considered and acted upon in a compliant fashion.

* To actively participate in Quality investigations, change controls and risk assessments associated with the projects to ensure Quality considerations are taken into account.

* To facilitate and lead structured investigations using recognised models such as “5 Whys” and “FMEA”.

* To perform the review and approval of a number of key documents associated to the projects including but not limited to validation, SOPs, change controls, investigations, risk assessments, pre manufacturing checks, facility release.

* To perform review of batch manufacturing records and release relevant material for the next stage of manufacture.

* To provide appropriate QA oversight of manufacturing and testing processes within the projects to support the business (including occasional out of hours).

* To participate in the data gathering/review for the quarterly trending reports and annual PQR.

* To provide training and coaching to more junior members of the team and to staff from other departments in order to promote a quality culture.

* To promote and enforce data integrity compliance across PBL.

* To liaise with customers, consultants and contractors as required.

* To provide support for departmental IPTs as required by performing all duties associated with the release of biopharmaceutical products.

* To escalate relevant issues to line management and/or to the QP.

* To provide KPI reports measuring the performance of the team.

* To undertake relevant training.

* To undertake work in accordance with the PBL Health and Safety policies and procedures and to work within any Quality Systems that are applicable to the site.

* To comply with PBL policies and procedures and core values and behaviours.

*Person Specification*

* Have current right to work in the UK;

* Possess a good standard of written and spoken English;

* Be educated to degree level or HND in relevant subject (e.g. Microbiology, or a related subject) or a demonstrable equivalent level of experience of working at a similar level in specialist area.

* Experienced in operating quality systems in a GMP environment with proven evidence of encountering a wide range of situations.

* Experience of preparing and providing accurate documents and reports in a timely fashion.

* Extensive experience of using an eQMS system in a QA environment.

* Excellent proven communication, tenacity and interpersonal skills.

* Ability to work with a minimum of supervision & to prioritise own work

* Strong customer focus

* Excellent personal effectiveness

* Excellent technical writing

* An understandingf and commitment toe quality of opportunity and good working relationships, both in terms of day-to-day working practices, but also in relation to management systems

For this unique opportunity to join our team and develop your biopharmaceutical career experience, please submit your CV and a covering letter. You should outline the skills and experience you have, which are relevant to the post for which you are applying. For more guidance on role requirements, please visit our website, portonbiopharma/careers, to download the Job Description.

PBL is an equal opportunities employer, celebrating and encouraging diversity of applications.

Porton Biopharma Ltd is committed to the fair and transparent processing of applicant data. To enable the Company to assess suitability for advertised roles, we will collect the following data: name and contact details, previous work experience and history, qualifications, education, right to work in the UK eligibility, present salary and equal opportunities. The Company reserves the right to collect this data under article 6(1)(B) of the GDPR.

Applicants applying for this role will have their data collected and held securely, and confidentially within Company IT systems which are compliant with GDPR. Data will be shared with the HR department, recruiting managers and recruiting panel.

The Company will hold applicant data on file for 12-months post the vacancy being successfully filled. Candidates are welcome to request that their personal data is removed prior to this date, and should contact if they wish to exercise this right. The Company complies with all data subject rights as outlined on the ICO Website. For more information, please refer to our privacy notice:

Company Description

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