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 Head of Quality Assurance for one of their sites.
The 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 Compliance
Duties:
- 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 required
Qualifications/Skills:
- Ideally Degree level education or track record in a similar position
- Oral Solid Dose and Generic Pharmaceuticals a plus
- Quality Assurance Management
- Ideally QP status although this isn't a deal breaker for exceptional candidates
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales