As Analytical Compliance Lead for Torbay Pharma you will play a key role in ensuring quality is woven into the way we work. This role incorporates utilising great cGMP and analytical chemistry knowledge to ensure regulatory compliance across both routine quality control and product development environments.
About Torbay Pharmaceuticals
At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner are now forging a new path in the private sector.
We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all our people begin their working lives in pharma. Together we can make lives better.
About the Role
Reporting into the QC Manager you will work alongside another Compliance Lead to provide compliance support to the Product Development Analytical Team and the Quality Control (QC) Team. The role will drive quality in the QC laboratory and act as quality support in the wider Product Development Team.
What you can expect in a compliance lead role at TP:
* Review protocols, reports, analytical methodology and raw data to ensure cGMP compliance
* Supporting investigations into deviations and out of specification results
* Lead on change controls that may impact the wider business and updating a wide range of documents as part of quality improvements such as raw material specifications
* Ensure regulatory compliance with the pharmaceutical quality system for all documentation and instrumentation used by the analytical team.
* Implementation of changes to support continued regulatory compliance.
* Review and approval of analytical data to ensure compliance to cGMP, data integrity and approved specifications.
* Ensure H&S requirements are met and maintained.
* Work within the wider development team supporting on quality and compliance related aspects of project management and research.
* Providing data packages for the QP group to review ahead of placing product on the market.
* Proposing and implementing changes to meet regulatory compliance and business growth.
* Ensuring documentation, assets, audits and training records are up to date in line with strict deadlines.
* Assist and lead where necessary on continuous improvement initiatives
What are we looking for:
* Familiarity with analytical instruments such as HPLC, UV-Vis, FT-IR, and ICP including a basic understanding behind behind the techniques and typical instrument functionality
* Strong understanding of general GxP principles (FDA, MHRA)
* Ability to manage own workload and work according to strict deadlines.
* Compliance/quality driven attitude with the ability to comment/propose changes for own area.
* Ensure data integrity is maintained, strictly observing confidentiality and compliance with the Data Protection Act and MHRA Data Integrity guidance.
* Good IT skills, with experience using lab based systems such as LIMS and Chromeleon
* Observance and awareness of all relevant safety regulations, e.g. Health & Safety at Work Act, COSHH etc.
* Excellent attention to detail with a right first-time approach to analytical and development data packages.
What we offer in return
At the heart of Torbay, we offer roles and career opportunities on your doorstep that you won't find elsewhere. With defined career pathways, and the chance to move between roles and different departments, we support your career journey at every stage. TP is going places. International expansion means growth and new opportunities.
Our benefits set us apart. With 27 days holiday as standard, group life assurance, pension and more - we reward our people for getting the job done.