Our lawsuit is an established pharmaceutical institution engaged successful the development, manufacture, selling and organisation of generic medicines successful the UK and Europe.
They connection a wide scope of high-quality medicines to the healthcare sector, that optimises outgo efficiencies whilst ensuring reliable supply. They are present looking to prosecute a Site Head of Quality to pb the Quality Assurance activities astatine 1 of the institution sites.
The tract Head of Quality volition pb the designated tract successful presumption of GMDP prime and compliance, including successful the areas of: QA, QC, GMP, GDP, QP activities and RP activities successful enactment with the concern goals and plan.
Responsibilities:
- Establish wide and compliant GMDP standards for each tract activities
- Align with the broader organisation, to guarantee organisation has azygous precocious standards
- Share champion practices, for the payment of the organisation
- Establish a wide site-level governance process, feeding the organisation committee
- Deliver wide and concise scorecards, connected a play basis, successful conjunction with the Site Director, including presumption and progress
- Deliver a play report, successful conjunction with the Site Director, communicating areas of challenge, transportation and risk
- Escalate issues of significance, successful a timely mode astatine tract level and beyond
- Lead and show a continuous betterment mindset (e.g. lean, six sigma etc.)
- Plan to person a deputy, susceptible of supporting robust operations, including erstwhile elder unit are absent oregon unavailable
- Lead connected Governance, Quality and H&S and Environmental matters
- Implement autarkic audit systems for interior audits of applicable departments
- Risk governance processes, looking astatine knowing and proactively managing tract risk
- Establish/Improve connected metrics, to show and recognize changes successful the show of the site, successful presumption of Compliance
Duties:
- Lead the tract Compliance Council process
- Lead regulatory inspections, linked to GMDP, H&S
- Deputise for the Site Director connected matters associated with Ethics and Compliance
- Build a narration with the regulators that interaction the site
- Support the gathering of a high-capability and high-delivery team, linked compliance, with the Company HR team
- Lead tract callback activities, arsenic required
- Manage DMRC communication, arsenic required
Qualifications
- Ideally Degree level acquisition oregon way grounds successful a akin position
- Life Sciences - Pharmaceutical manufacture and Distribution
- Oral Solid Dose and Generics
- Quality Assurance Management of tract level activities
To find retired much astir Real delight sojourn www.realstaffing.com
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