International Pharmaceutical Manufacturer seeks an experienced Biochemistry Technical Specialist.
About the role:
To support the laboratory by providing specialist knowledge and problem-solving ability for all tests, problematic results, and validation requirements across the section and working as the subject matter lead.
Duties may include:
To assist with the delivery of departmental objectives.
Provide technical support for critical deviations.
Support site driven investigations and improvements
Lead the departmental OE initiatives, empowering staff to identify improvements. Reviewing and approving improvements, enabling staff to deliver for leaner ways of working.
An SME for Quality Records, providing the training and support for inexperienced member of staff to increase their knowledge/ability in completing quality records.
SME supporting department in quality records for technical issues/guidance.
To assist with the implementation of change controls and to implement agreed actions.
Support improvements to the training programme and assessment criteria.
Identifying the need for procedure updates and ensuring correct procedures are in place.
Act with delegated decision-making authority for the Quality Manager as and when required.
Preparation of technical documentation such as procedures, protocols and reports.
Support and help deliver validation activities identified by the business and Quality manager, working closely with the technical development department.
Attend AMF meetings as an active member, providing updates on activities and setting of reasonable timelines for completion of work required by the department dependent on other activities being undertaken by the group.
Liaising with Team Leader to ensure available resource to enable delivery of work for the business is achieved.
Support preparation of departmental CAPEX requirements
Assisting with the development of training programmes.
Working with Quality Manager to implement and support projects within the laboratory and across manufacturing.
Ensure that agreed laboratory and project timelines are implemented and achieved.
To ensure that the calibration or validation of laboratory equipment and automated systems is performed.
Maintain familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to assist the Quality Manager.
To support technology transfer and projects.
To take the lead on trouble shooting instruments and assays to fix problems and maximise performance.
To take responsibility for and deliver training and coaching to all members of the department.
Ensure work is in line with regulatory requirements and guidelines.
To participate with the receipt of audits from internal and external sources.
To adhere to record and data integrity requirements, as per polices.
Provide specialist advice to the Quality Manager for problem solving and fault diagnosis.
To be the subject matter experts in relation to the work of the section.
Preparing documents and responses for regulatory submission.
Skills and experience:
Significant experience in a laboratory environment, with a focus on a specialist discipline
Good knowledge/understanding of GMP/GLP.
Experience in OOS and invalid assay investigations.
Experience of raising, completing, and investigating quality records.
Project management experience.
Knowledge of industry guidelines.
Experience of writing protocols and reports
BSc in relevant subject (or equivalent experience)