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Job Description
- Preparing Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
- Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods.
- Stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate.
- Writing analytical specifications using current pharmacopeias and reviewing existing analytical specifications.
- Writing/reviewing Standard Operating Procedures (SOPs).
- Calibrating analytical equipment, as and when required.
- Supporting all QC activities.
- Ensuring that procedures are carried out carefully and accurately to eliminate errors.
- Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
- Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
- Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Observing and complying with company Health and Safety Policies.
- Observing and complying with company Standard Operating Procedures (SOPs).
- Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
Job Requirements
- Highly proficient in the use of key analytical equipment (HPLC, IR, UV) and the testing of finished products.
- Experience of working in a GMP environment.
- Good IT skills e.g. Microsoft Office (Word, Excel and Outlook).
- Credible and confident communicator (written and verbal) at all levels.
- Highly customer-focused and passionate about delivering excellent customer service.
- Ability to achieve and maintain high standards with meticulous attention to detail.
- First-class planning, organizational and time management skills.
- Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales.
- Strong analytical and problem-solving ability.
- Self-starter who can ‘hit the ground running’.
- First-class team player with a totally flexible approach.
- Self motivated with the ability to work proactively using own initiative.
- Hands on approach with a ‘can do’ attitude.
- Committed to learning and development.