Description
We are seeking an Analytical Development Chemist to assist the Analytical Tech Transfer Manager in ensuring that testing activities or methods and specifications introduced or changed as part of product lifecycle are validated or verified in compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements.
Key Responsibilities:
- Draft, compile, review and update laboratory documents such as analytical methods and specifications, method validation/equivalency protocols/reports, local procedures and guidelines relating to GMP and operational framework of the laboratory
- Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue
- Contribute to the formulation and development of plans for the implementation of new or improved testing technologies and/or methods for products and/or cleaning processes
- Ensure a safe working environment for the laboratory through participating or issuing safety risk assessments for product-specific methods, techniques or materials and performing 6S inspections
- Lead or participate in investigations arising from laboratory investigations, incidents and accurately assess the impact of the failure to make appropriate recommendations for remedial or CAPA actions for follow-up
Knowledge, Skills & Experience:
- Open to fresh graduates with a minimum degree in chemistry or related field
- Minimum 3 years experience in an analytical environment, preferably in the pharmaceutical or regulated industry
- Good knowledge of GMP
- Understanding of product specification and method analysis
- Knowledge of laboratory instrumentation
- Laboratory support procedures
- Regulatory requirements for method validation
- Good communication skills
- Problem-solving skills
- Project management skills