Industry: Pharmaceutical Production / Technology / Product Support
Salary: Up to £27.2k
Training: Yes (Full).
To undertake chemical and biochemical analyses to support the manufacture of the clients licensed pharmaceutical products; as required by EU Directive 91/356/EEC for GMP compliance. To supervise and schedule work for QC Technologists. To write quality documentation relating to raw materials, water and product testing. To ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements
MAIN DUTIES AND RESPONSIBILITIES
- To deputise for the QC Analytical Lab Manager when required.
- To supervise Junior QC Analytical staff.
- To schedule work for QC Analytical staff members to ensure that
- manufacturing deadlines are met.
- To ensure analysis and recording of QC and stability testing has been
- performed in compliance with the statutory requirements of cGMP.
- Responsibility for testing raw materials samples to ensure that they meet the specifications established in the product licence and internal specification documents.
- Responsible for writing Standard Operating Procedures and their associated
- risk assessments to ensure that those tasks are performed safely.
- Organise and liaise with external testing laboratories to arrange correct and on
- time testing to meet production deadlines.
- Maintain an up-to-date awareness of regulatory and scientific developments via
- courses, meetings and literature.
- Responsible for the verification of analytical raw data and release of results
- from the QC Analytical department.
- Responsible for writing quality records such as non-conformances, CAPAs and
- change controls.
- Undertake work in accordance with the clients Code of Safety
- Practice and Quality Systems.
- Support other QC teams including in-process and finished product testing
- where required.
- Degree in Chemistry/Biochemistry or other suitable degree.
- Suitable experience may be considered as suitable
- Further degree in Chemistry, Biochemistry or equivalent discipline / membership of a scientific society.
KNOWLEDGE AND EXPERIENCE
- Working Knowledge / Experience of cGMP.
- Working Knowledge / Experience of the EP and USP.
- Working Knowledge / Experience of ICH requirements.
- Previously worked in a similar laboratory as a bench analyst following written instructions and comparing analytical results with set specifications.
- Experience of the out of specification process and carrying out laboratory investigations.
- Experience using standard analytical laboratory equipment such as pH meters, balances, pipettes.
- Knowledge / Experience analysing pharmaceutical raw materials.
- Ability to supervise junior staff and schedule workloads.
- Experienced in supervising junior staff and scheduling workloads in a similar situation.
SKILLS & CAPABILITIES
- Good communication skills able to communicate technical issues clearly, both written and verbally with QC and other PBL staff.
- Problem solving skills and ability to respond to sudden unexpected demands.
- Ability to work on own initiative, organise own workload and prioritise daily work with minimal supervision working to tight and often changing timescales.
- Ability to use technical software packages.
- Ability to cooperate with and take part in team based activities.
- Good basic computer skills and literacy.
- A desire and ability to self-improve and to improve the department.
- Able to logically troubleshoot QC analysis.
- Able to verify QC data with a good eye for detail.
- Able to apply theoretical knowledge to practical situations.
PORTON DOWN / WILTSHIRE / SALISBURY / MANUFACTURING / ANALYSIS / PHARMACEUTICALS / GMP / CHEMISTRY / LABORATORY / BIOCHEMITSRY / MANUFACTURE / MANAGEMENT / ENGINEERING / BIOPHARMACEUTICAL / INVESTIGATIONS / LEADERSHIP / SOFTWARE / DOCUMENTS / QUALITY CONTROL / PROCEDURES / ICH / EP / USP / ENZYME