- Experience Level
An international pharmaceutical company is advertising a vacancy for a QMS Consultant, based in the company's office in Wales. The QMS Consultant will support the effective functioning of the company's Quality Management System, providing assistance to the Quality Assurance Department as required.
- Act as the responsible SME in coordinating and maintaining all activities required for the disposition of finished product by Qualified Persons.
- Act as the responsible SME for the compliant maintenance of the Quality Assurance Department inclusive of QMS actions, QE's, CAPA, CC's etc.
- Act as the responsible SME to 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 BTG 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.
- To be responsible for the artwork approval process.
- 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 Manager role and deputise for the QA Manager role as appropriate.
- Ensure 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 BTG values.
- Carry out other reasonable tasks as required by the Line Manager.
Skills and Requirements:
- Educated to degree level or equivalent in an appropriate scientific discipline such as Chemistry, Biochemistry, Microbiology, Pharmacy, or Life Sciences.
- Educational background should be supported by proven experience in an appropriate Quality role within the Pharmaceutical/Biotechnology industry.
- Experience of working within a regulated industry.
- Capability of analysing quality data and detect trends.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.