Deputize for Team Lead, Analytical Laboratory as required including providing technical and problem-solving support to the team as required.
Aid in the development of new methods and conduct testing and software validation activity as required.
Carry out project work as required, particularly associated with the implementation of new specifications and methods of analysis required to comply with pharmacopeia or customer requirements.
Review/Approve Qualification of equipment used in the lab.
Perform analytical testing in accordance with associated regulatory and procedural requirements and ensure that laboratory documentation is kept up to date at all times.
In depth knowledge of Agilent HPLC’s, Empower, Pharmspec and Chemstation Software required.
Receipt and log-in of samples for testing.
Daily monitoring and verification of laboratory equipment and completion of associated paperwork.
Perform instrument calibration and maintenance and review and approval of associated documentation as required.
Review/Approve laboratory testing data as required and reports for release testing of finished product and raw materials analysis.
Review and Approve laboratory investigations in a timely manner as required.
Review and Approve laboratory investigations in a timely manner as required.
In depth knowledge of Agilent HPLC’s, Empower, Pharmspec and Chemstation Software required.
Laboratory purchasing and inventory control as required.
Maintain laboratory in a clean and well organised status at all times.
Delegate for Microbiologist where trained on relevant procedures/tasks.
Participate in audits (internal and external) and inspections and implement CAPA outcomes as appropriate.
Comply with GLP/ GMP and safety requirements at all times.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications
Candidates must possess a third level qualification (degree level) in chemistry/science related discipline.
The ideal candidate should possess at least 3 years’ experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry.
Candidates must be strong technically with the ability to troubleshoot HPLC, and/or dissolution in addition to other analytical instrumentation. Candidates must be capable of working on their own initiative and also be comfortable within a team environment.
Willingness and availability to travel on company business.
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Cook Medical is proud to be an equal opportunity employer and we know that diversity makes us stronger and better as a company. Every day we make life-saving products and do what is best for patients worldwide, and the people that join Cook make this possible. In keeping with our Cook Group values, we are committed to treating all employees equally regardless of gender, civil status, family status, sexual orientation, religious belief, age, disability, race or membership of the traveller community. It is our policy to ensure that as much accommodation as possible is carried out to facilitate the participation of all individuals to ensure equity in the recruitment process and in the workplace
