Kindeva is passionate about helping you realise the full potential of your career. We have the vision to see what’s possible, the expertise to make it happen and the agility to overcome any challenge along the way.
Kindeva is navigating a period of dynamic change and growth.We are looking for a talented QC Laboratory Analyst to join our team.
Summary of Position
Supporting Kindeva’s QC Stability Group, this role will be responsible for writing of Stability protocols, setting up stability studies and writing stability reports. Working across cross-functional teams to support stability activities and ensuring Good Documentation Practices.The employee would represent the department as required to include external customers and regulators.
Other responsibilities and tasks that are deemed appropriate by supervision will also be required to be performed by the candidate.
Job Responsibilities
Safety
* Knowledge and application of current safety regulations (e.g., CoSHH) as applicable to laboratory functions
GMP
* Follow the 10 rules of GMP
* Work to appropriate laboratory systems, standards and procedures, e.g., data recording, labelling, investigation and calibration procedures. Complete analytical documentation including the input of results onto the LIMS system.
* Awareness of current regulatory standards as applicable to laboratory functions.
* Maintain good laboratory housekeeping.
* Champion GMP / GLP standards and principles within the laboratory area.
Stability/ Documentation
* Able to interpret analytical data and use knowledge to effectively write stability protocols, set up studies and write reports to support stability testing. Identify and implement appropriate investigative documentation.
* Write, update, review and issue GMP documentation where full training has been received.
Product, Equipment and Process Knowledge
* Have knowledge of pharmaceutical products and testing.
* Develop an understanding of the tests carried out and their impact on the products / materials worked on.
* ·Responsible for the maintenance and calibration of laboratory and stability equipment.
* Support continuous improvement activities within own group.
* Participate as a team member for Group CI projects as appropriate.
Audits
* Have a general understanding of how to communicate with auditors and general employee expectations during an audit.
* Able to present answers to audit questions to an auditor during an internal audit.
Time Management
* Have a basic understanding of the resources required to perform stability-based activities.
Please note that this is not an exhaustive list of responsibilities.
Skills & Experience
* Must have BTEC HND with 3-5 years of relevant experience
* 240 OU points in relevant discipline
* Must have worked with GLP, GMP, Specifications and Test Methods
* Must have 1 year of experience of testing within the Pharmaceutical Laboratory
* Knowledge of pharmaceutical testing requirements, testing equipment and current Analytical techniques.
Benefits Life Assurance Company Pensions Scheme Employee Assistance Program 25 days holiday per year increasing by 1 day every 5 years up to an additional 5 days
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