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Quality Specialist - Pharmaceutical
Job Posted: 5 days ago
Salary: £ 30,000/Annum
Job Type: Permanent
Location: Bolton
Expire in: 23 days
Job Description
We are recruiting for a Quality Specialist to join a growing Pharmaceutical business and play a key role in the company's continued growth.
About the business:
This organisation is well established, have a diverse customer base and are well geared for growth in the coming years. The business supply a range of pharmaceutical products into multiple segments of the healthcare sector and have a strong reputation as one of the leaders within this field
They have a diverse and inclusive team and you will get the opportunity to work alongside a talented Quality team, to play a key role in driving a positive quality culture.
About the Quality Specialist role:
The Quality Specialist will be responsible for administration and database control within the department. You will provide administrative support to customers and colleagues, whilst being responsible for maintaining databases such as error recording, enquiries, final release, CAPA and QMS.
The scope will also include overseeing the quality of all products manufactured or sourced by the company and ensure adherence to GMP, GDP, documented procedures and work instructions.
Some of the key responsibilities for the Quality Specialist will involve the following:
Promoting Quality Compliance (GMP) within the site and comply with company policies.
Review Finished Batch Record and GMP Release for final QP Release.
Oversee and input to QMS related Change Control, Non-conformance and CAPA's.
Develop, Enhance and update the Quality Management System (QMS) activities associated with the release of product, integrating as appropriate into central activities.
Ensure appropriate maintenance of filing of Quality related documents, including Deviations and CAPA’s.
Maintain all QA databases which include but are not limited to QMS, master list, quality metrics, errors, daily orders, product enquiries and documents.
Support in product enquiries ensuring timely responses.
Control and maintenance of Quality documentation, including generating, reviewing, issuing SOPs, forms and BMRs.
Liaise with suppliers in order to obtain documents needed for Quality Approval such as leaflets, cartons and licenses.
Documentation writing including reports, recording deviations, non-compliances and other quality related forms.
Coordinate and manage to resolve customer complaints, recalls, change controls, ensuring proper root cause analysis and prompt responses/resolution. The successful candidate for the Quality Specialist role will have the following background:
Prior experience working in a Quality function, as a Quality Specialist / Quality Officer within the Pharmaceutical industry.
A Scientific Degree Qualified, along with credible industry relevant training.
Batch release experience is highly desirable.
Good understanding of Good Manufacturing Practice (GMP).
A team player, who enjoys working with others to drive positive change within a complex environment Keywords: Quality Specialist, Quality Officer, QA Specialist, QA Officer, Quality Assurance, QMS, Quality Management SystemBefore You Apply
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