Summary: Are you an experienced Quality Assurance Officer who has worked in a Pharmaceutical Manufacturing environment before?
If so then carry on reading!
Description: Are you an experienced Quality Assurance Officer who has worked in a Pharmaceutical Manufacturing environment?
Can you help to support the production and operations to ensure the effective execution of the company quality system requirements in assuring pharmaceutical products are manufactured in accordance with the relevant Marketing Authorisations and in compliance with GMP and regulatory requirements?
Main responsibilities: -
* Ensure compliance of production operations to GMP and company requirements
* Proactively identify and support the implementation of continuous improvement opportunities in QA and Production Operations
* Provides routine support and advice to Production Operations on quality related issues
* Ensure the timely communication of significant GMP and/or product quality issues to QA and Production management
* Leads investigations in a timely manner, identifying root causes and driving continuous improvement and CAPA
* Assess and advise in the event of deviations and planned changes
* Assist in audit and compliance activities (self-inspections, external audits and regulatory inspections)
* Assist with quality management reviews
* Facilitate the approval of product batches through collation, review and approval of batch documentation to the QP in accordance with the company batch document review system
* Perform inspection and approval of primary and secondary packaging materials as required
* Performs risk assessments
* Assist the company Qualified Person in carrying out their own duties
* Comply with H&S, GMP and internal Company policies
For this role with a wide salary bracket of £25,000-£40,000 (based on a grading structure and experience) There is also a well-paid shift premium of nearly £5000 per annum for working a split shift Monday-Friday. There are also additional general benefits on top too.
The background I am seeking in you: -
* Excellent working knowledge of a Quality Management system and its processes
* GMP as outlined in Directive 2003/94/EC.
* At least 2 years practical experience in QA working with a Pharmaceutical Quality System
* Understands the relevant ICH guidelines
* By collaboratively working alongside Senior QA officers and QPs will require minimum supervision working in pre-defined parameters on the Quality Management System (QMS):
* Auditing and self-inspections
* Management of quality and GMP at approved vendors and contractors
* Deviations, root cause analysis, corrective and preventive actions
* Change control
* Quality risk management
* Support in Product Quality Defects and Product Recalls
* Understand validation principles
* Be able to draft reports for review by a senior member of the team
* Perform reviews of quality documents ranging from batch records, packaging documents and standard operating procedures
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
At this moment in time and due to the excellent salary on offer they are only considering previous QC Pharmaceutical Laboratory experience where you have worked to Good Laboratory Practice (GLP) principles.
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