Senior QA Officer - CAPA - GMP - Northamptonshire - £30k-£40k

Location
Daventry, England
Salary
GBP30000.00 - GBP40000.00 per annum
Posted
Sep 06, 2016
Closes
Oct 04, 2016
Ref
BBBH4383
Contact
Katie Pink
Discipline
Clinical, Quality
Result Type
Jobs
Position Type
Permanent
Hours
Full Time



Senior QA Officer - CAPA - GMP - Northamptonshire - £30k-£40k

A growing pharmaceutical manufacturing company requires an experienced Senior QA Officer to support the QA division. You will assist the Head of Quality Assurance, in the day to day operation of the Quality Management System and development of additional systems and processes of the manufacturing. You will have a degree in a scientific discipline and have significant experience in a pharmaceutical QA role.

Job Responsibilities:

*Assist, Head -Quality Assurance, in the day to day operation of the Quality Management System and development of additional systems and processes of the manufacturing site
*Participation in quality based projects in relation to manufacturing activities.
*To work with other departments to ensure a strong QA culture throughout the business.
*Handling of Change Control and CAPA processes.
*Investigating and closing change control, deviations, CAPAs, self-inspections.
*Investigating and closing product quality complaints, Incidents.
*Experience in writing and implementing Standard Operating Procedures.
*Understanding of various dosage forms with emphasis on Liquid Oral Manufacturing.
*Analysing, trending and reporting of data.
*Understanding of Product Quality Review requirements.
*Implementation and maintenance of a quality assurance system for the site.
*Co-ordination of documentation control activities, liaising with appropriate personnel to progress updates and approvals.
*Writing, reviewing, distributing and filing/archiving of completed Quality System documents.
*Batch document review for product release.
*Conducting internal audits and supporting third party supplier audits.
*Support Notified Body and Regulatory Authorities inspections.
*Ensure legislative/regulatory changes are communicated and embedded in the Quality System. Support maintenance of the Supplier Approval programme.

Essential skills and experience:

*University degree in a science discipline.
*Significant Pharmaceutical Industry experience in a similar Quality Assurance related role in the Pharmaceutical Industry.
*Good understating of GMP and GDP and FDA or MHRA and any other relevant guidelines/updates.
*Knowledge of EU and UK quality related pharmaceutical regulations.
*Good understanding of Pharmaceutical Quality Management System and its functions: change control, deviations, CAPAs, self-inspections.
*Good administration and communications skills required for internal and external contacts.
*Conversant with MS Office applications.
* Good interpersonal skills and ability to work well within the organisation.
*Ability to work under pressure, Excellent time management and self-organisation.

Apply for Senior QA Officer - CAPA - GMP - Northamptonshire - £30k-£40k

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