Description
Our client requires a new QA Manufacturing Operations Specialist.Key responsibilities of the role may include:
- QA support of manufacturing operations through start-up and onto routine commercial operations.
- Implementation of batch record review process and on the-floor support of manufacturing activities.
- QA Operations review of events and investigations.
- Authoring, review and approval of QA-related procedures.
- Review and approval of functional area documentation.
- Support the Disposition process for Drug Substance and ensure material availability for Manufacturing through release of raw materials and consumables.
- Participation in GMP reviews for new facility construction and new equipment support systems.
- QA support for the development of batch records.
- Change control assessment and CAPA evaluation/CAPA close-out.
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
- Support OPEX programs and champion continuous quality improvement initiatives.
- BSc in Science or related discipline with 2 years' minimum QA or related experience in a pharmaceutical environment.
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team Matrix in order to meet accelerated timelines.
- Excellent communication & presentation skills are essential.
- Excellent time management & organisational skills along with a proven ability to multi-task.