QA Associate - Manufacturing
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .
To operate, administer, maintain, develop and continuously improve the routine systems operated by the QA Department for example Document Control and Issue, Change Control, Investigations and Corrective & Preventative Actions (CAPA), Materials Assurance, Auditing, Qualification and Validation, Manufacturing and QC documentation review and Training.
1. Administer, maintain, and continuously improve any assigned QA systems, which may include, Document Control and Issue, Change Control, Events Deviations & Non Conformances, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training.
2. Operate core QA events, deviation, non conformance, change control, and document writing and review processes as instructed by QA Management.
3. Ensure self and colleagues have no overdue training, or site actions.
4. Train staff in own and other areas as required in specific tasks related to job role.
5. Ensure local work processes are continuously improved and any efficiency gains are captured in work instructions or guidance notes.
6. Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self and team.
7. Represent own work on quality records (Change controls, Batch Manufacturing Record, validation documentation etc.) in customer audits.
8. Where appropriately trained be able to deputise for and carry out the duties of nominated QA personnel of similar grade.
Essential Skills / Qualifications:
1. Minimum of one A level in a science based subjects or similar qualification or equivalent competence demonstrated by experience.
2. Must be able to work effectively and accurately when balancing conflicting priorities or handling large amounts of information, data or documentation.
3. Be able to identify when escalation to management is required with regard to conflicts in work or problems are identified.
4. Must be a flexible, self starting team player, able to work with minimum supervision, who possesses good organisational, time management and interpersonal skills and is able to deliver high quality and accurate work.
Desirable Skills / Qualifications:
1. Support the team in the delivery of all Business Programmes as required.
2. Build and maintain good working relationships with Manufacturing. Work with manufacturing personnel to improve compliance and feedback learning.
3. Ensure that all relevant documentation is made available for batch disposition including the requirements of the disposition pack.
4. Responsible for the review of data to support customers regulatory submissions.