We are currently supporting one of our clients with the recruitment of Quality Assurance Specialists. There are two roles, one would suit a graduate with 1/2 years experience, the other a more experienced QA Specialist with 5/6 years experience of working within a pharmaceutical setting. Our client offers drug development solutions and has focus on progressing innovative products for pharmaceutical and biotech organisations.
The role involves supporting in the running of the site’s Quality Management System (QMS) and supporting the cGMP manufacture of both developmental and commercial Active Pharmaceutical Ingredients, this may include associated analytical activities
The ideal candidate will have in depth previous experience of working in a CMO environment, preferably within an API manufacturer. Experience in the review of batch records in a chemical manufacturing plant is desirable.
Duties
- Being involved in the review of manufacturing batch records, cleaning documentation and associated analytical data.
- Provide Quality oversight activities across the site including the assurance of facility and equipment calibration and maintenance, and provide technical GMP support to the Production and Analytical departments and Clients as required.
- Conduct internal audits.
- Change Controls
- CAPA's
- Participate in GMP training of personnel involved in manufacturing and conduct GMP compliance projects across the site.
- Identify issues and participate in the investigation of problems to identify root causes associated with deviations and OOS investigations. Work with API Development department to find resolutions to any non-conformances identified.
- Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance
- Cleaning experience
- Method Validation
- Administration of the site’s GMP systems and processes
Qualifications
- Degree qualified in Chemistry or related field.
- Knowledge and experience of working with quality programs such as cGMP/ICH Q7, and maintain cGMP compliance.
- The ability to coordinate multiple priorities in a fast paced environment.
- Work effectively and efficiently in a cross functional team environment.
This is a fantastic opportunity to work within a dedicated QA Team within a highly successful Contract Manufacturing Organisation.