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Pharmaceutical Laboratory Analyst - United Kingdom - Kindeva Drug Delivery Company
Description
Posted Wednesday, February 28, 2024 at 5:00 AMKindeva is passionate about helping you realize 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 Technician to join our team.
Summary of Position
Rotating between Kindeva's Investigations Team and Analytical Team, this role will be responsible for testing of pharmaceutical raw materials (including components), intermediates and finished products for batch release, stability, development studies and customer complaints in line with the site procedures.
Within the investigations team the role would include completion of preliminary and full scale investigations with the implementation of problem solving techniques, root cause analysis and effective CAPAs.
The employee would represent the department as required to include external customers and regulators.Providing support and technical guidance for direct reports and other members of the team.
Other responsibilities are included in EPR along with other tasks that may be deemed appropriate by supervision.
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
Analytical Testing
Perform analytical testing using methods where training has been received with minimal avoidable errors in order to meet scheduled timelines.
Perform new test methods and techniques once full training has been received.Provide support / technical expertise to resolve problems with analytical testing.
Complete preliminary investigations. Complete full-scale investigations with minimal support.
Review and issue
GMPdocumentation 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, calibration and validation of laboratory equipment.
Participate as a team member for Site 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 laboratory-based activities.
Able to create basic project plans to detail activities and proposed timelines for laboratory / function-based activities.
Develop an understanding of project planning tools used within Kindeva.
Please note that this is not an exhaustive list of responsibilities.
Skills & Experience
Must have BTEC HND with 3+ 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
Must have hands on experience of HPLC, and UV techniques
Must have GLC experience
Knowledge of pharmaceutical testing requirements, testing equipment and current Analytical techniques.
What we will give to you:
Attractive compensation package
Company pension scheme (up to 10% employer contribution)
25 days holiday per year (plus bank holidays) plus service days after 5 years
Company sick pay
Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
Life assurance of four times life cover salary
Flexible working hours (not to be included for shift working)
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