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Job Description
QC Raw Materials and Compendial Scientist
Responsible for ensuring the highest standards of GMP, GLP, and Regulatory are strictly adhered to in the QC testing and release of raw materials.
- Ensure tasks associated with the startup and routine operations of a QC Raw Materials and Compendial laboratory are carried out in a safe manner.
- Support QC Raw Materials and Compendial laboratory set-up, including laboratory design, equipment installation and qualification.
- Develop and maintain quality systems within the QC Raw Materials and Compendial laboratory to ensure compliance to GMP / GLP.
- Support and lead QC test method validation and development of routine testing strategies when required.
- Perform additional duties at the request of the direct manager.
- Routine monitoring of laboratory KPIs, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
- Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
- Author technical documents including methods protocols, qualification/validation protocols and reports, SOPs, etc.
- Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations.
- Develop and maintain high level of scientific achievements for the company.
- Ability to handle regulatory inspections from FDA, EMA, etc. and c GMP audits from clients, as well as internal audits.
- Participate in relevant internal and external QC related audits.
- Ability to work in a team environment and independently as required.
- Train other QC analysts and manufacturing personnel in laboratory methods and procedures when required.
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and Wu Xi Biologics Policies and Standard Operating Procedures.
Requirements
- University degree in related science/quality discipline required.
- Excellent communication, interpersonal and presentation skills.
- Ability to think critically and demonstrate troubleshooting and problem solving skills.
- Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
- Collaborative and inclusive approach to work and your colleagues.
- Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
- Autonomous and a self-starter who will use their initiative to drive actions forward.
- Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations.
Benefits
- Bonus
- Canteen
- Life Assurance
- Paid Holidays
- Parking
- Pension
- VHI