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Site Head of Quality Assurance
Job Posted: 16 days ago
Salary: £ 110,000/Annum
Job Type: Permanent
Location: Wingate, County Durham
Expire in: 11 days
Job Description
Our client is an established pharmaceutical company engaged in the development, manufacture, marketing and distribution of generic medicines in the UK and Europe.
They offer a wide range of high-quality medicines to the healthcare sector, that optimises cost efficiency whilst ensuring reliable supply. They are now looking to hire a Site Head of Quality Assurance for their site in the North East.
The Site Head of Quality Assurance will lead the designated site in terms of compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities.
Responsibilities:
Establish clear and compliant GMP/GDP standards for all site activities
Align with the broader organisation, to ensure organisation has uniform high standards
Share best practices, for the benefit of the organisation in relation to QA
Establish a clear site-level governance process, feeding the organisation committee
Deliver clear and concise scorecards, on a weekly basis, in conjunction with the Site Director, including status and progress
The Head of Quality Assurance will deliver a weekly report, in conjunction with the Site Director, communicating areas of challenge, delivery and risk
Escalate issues of significance, in a timely manner at site level and beyond
Lead and demonstrate a continuous improvement mindset (e.g. lean, six sigma etc.)
Plan to have a deputy, capable of supporting operations, including when senior staff are absent or unavailable
Lead on Governance, Quality and H&S and Environmental matters
The Head of Quality Assurance will implement independent audit systems for internal audits of relevant departments
Risk governance processes, looking at understanding and proactively managing site risk
Establish/Improve on metrics, to demonstrate and understand changes in the performance of the site, in terms of ComplianceDuties:
Lead the site Compliance Council process
Lead regulatory inspections, linked to GMDP, H&S etc.
Deputise for the Site Director on matters associated with Ethics and Compliance
Build a relationship with the regulators that impact the site e.g. MHRA etc.
Support the building of a high-capability and high-delivery team, linked compliance, with the Company HR team
Lead site recall activities, as required
Manage DMRC communication, as requiredQualifications/Skills:
Ideally Degree level education or track record in a similar position
Solid Dose and Generic Pharmaceuticals
Quality Assurance Management
Ideally QP status although this isn't a deal breakerTo find out more about Real, please visitBefore You Apply
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