GxP Recruitment invites applications on behalf of our biopharmaceutical client based in Grangemouth, Scotland. Due to continuing expansion an excellent opportunity now exists for a QA Technician to join their team on a fixed contract initially for 12 months with company benefits.
* Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
* Participate in quality related investigations, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
* Identify and escalate any identified cGMP areas of concern.
* Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures
* Participate in the audits of suppliers, production and support functions as required.
* Be involved in the preparation for MHRA/FDA and other regulatory body audits.
* Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
* Reviewing manufacturing, laboratory and associated documentation prior to performing the relevant disposition of final products. Where potential issues exist, these are to be highlighted to the QA manager.
* Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC and manufacturing thus ensuring that all cGMP documents are appropriate, and all cGMP requirements are satisfied.
Candidates must have the following:
* Attention to detail
* Good communication skills, both verbal and written
* Good organisation skills
* Ability to work effectively individually and as part of a team
* Ability to analyse data and information to make considered decisions
* The ability to identify root cause of problems to determine appropriate solutions
* Ability to prioritise workload to ensure timelines are met
* Ability to follow instruction accurately
* Ability to escalate issues as appropriate
* Previous experience within a cGMP environment manufacturing Active Pharmaceutical Ingredients is required.
* A College/University qualification in a scientific subject is required.
* Experience in dealing with quality assurance, analytical chemistry, development, and manufacturing groups is beneficial