NEW PROCESS INTRODUCTION (NPI) OFFICERFixed Term Contract (FTC)CENTRAL BELTSRG are currently recruiting a New Process Introduction (NPI) Officer for a rapidly expanding pharmaceutical company on...
Are you an experienced QA Officer who has worked within a cGMP manufacturing environment?
SRG have a fantastic opportunity to join a successful and expanding contract manufacturing organisation in the Central Belt of Scotland.
Role:To act as the Quality Assurance contact for review of procedures, completed batch paperwork including manufacturing and analytical documentation. Be the QA representative for new campaigns dealing with aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition. To identify and escalate cGMP issues that have the ability to effect batch quality.
- Provide QA input to project activities including review and approval of change requests, specifications, SOPs, Manufacturing Procedures and Analytical
- Participate in quality related investigations; assist in the development and approval of effective CAPAs
- Identify and escalate any identified cGMP areas of concern.
- Participate in validation activities
- Participate in the audits of suppliers, production and support functions -
- Be involved in the preparation for regulatory body audits.
- Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
- Knowledge of applicable cGMP regulations.
- Attention to detail.
- Ability to identify potential issues and consider the associated risk.
- Excellent communication skills and ability to influence.
Qualifications & Experience
- Experience within a cGMP environment
- Experience in dealing with quality assurance; including raising deviations and CAPAS.
- Experience in analytical chemistry, development, and manufacturing groups
- A College/University qualification in a scientific subject is required.
Please apply online or contact Emma for more information if you feel you have the relevant skill and experience to be considered for this role.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.