Senior Quality Assurance Officer
An exciting opportunity has arisen to join a leading pharmaceutical client as a Senior Quality Assurance Officer. The organisation formulates and manufactures various health technologies, including MDIs, DPIs, and Small Volume Liquids. Based in Runcorn, this position is an exciting opportunity to work with a company with over 30 years of experience in the industry.
- Ensure batches are QA reviewed as required to support the business needs.
- Ensure deviations, CAPA, and change control for which you are the owner are progressed in a compliant and timely manner.
- Ensure deviations, CAPA, and change controls are reviewed and/or approved in accordance with internal procedures.
- Ensure customer complaints are satisfactorily investigated and communicated.
- Participate and/or host internal audits and in-risk assessments.
- Ensure the organisation/coordination of QAO workload is appropriate to facilitate right first-time performance and reporting/recording of the manufacturing, testing, and release of pharmaceuticals by the company.
- Ensure the effective performance of monitoring, reporting, and escalation of Quality performance indicators through the QA department to the QP, Head of Quality, and functional peers/leaders within the company.
- Support in the training and development of QAOs as required.
- Provide guidance/advice on Quality considerations within manufacture, testing, reporting, and release of pharmaceuticals as required by functional peers across the company.
- Support the maintenance of the site QMS and facilitate reporting of relevant KPIs within department and across site as required.
- Conceive, define, and deliver Quality related improvements projects.
- Any other activity deemed quality related by the Head of Quality.
Skills and Requirements:
- Scientific degree or significant experience with a relevant role.
- Understanding of quality management systems.
- Awareness of applicable GMP requirements.
- Ability to identify and raise deviations from above.
- Ability to root cause deviations.
- Competent to follow all site policies, GMP, H&S rules, and report if not followed.
- Responsibility for own area for H&S, along with all other employees and managers.
- 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 Josh Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical 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.