- To support the Head of Quality and the R&D Quality Assurance Manager & Team Lead with the quality assurance function.
- Support R&D with QA support including but not limited to the following:
- batch documentation review
- assessment of manufacturing events from a QA perspective.
- Electronic Documentation Management System
- Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation.
- QA reviewer of Process Compliance Change Controls
- Progress Process Compliance actions and attach evidence as required.
- Perform internal audits as scheduled.
- Review and approval of Regulatory deficiency responses.
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Report any safety or compliance issues as per company procedures.
- Attend Product review meetings and provide support on the development of new Products
- Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
- Assist with review of Submission Documentation in support of license applications and customer requirements.
- Noncompliance reporting and corrective action / continuous improvement implementation.
- Operation of SAP Quality function as per procedures.
- Support the on-going OOS/IR/CACI closeout programme.
- Complete any assigned actions in the agreed time frame.
- Investigate any incident assigned in a timely fashion.
- Review deviation investigations and actions as required.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Report any hazards
Minimum Qualifications and Experience:
- BSc (Require Quality Management as a part of degree)
- Minimum of 2 – 4 years QA experience in a GMP compliant role
- Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
- Excellent communication and presentation skills
- Focus on quality and detail
- Careful planning to achieve accurate and timely results
- Ability to define and manage own tasks and schedules
- Experience performing and assessing risk/impact assessment an advantage
- Sterile manufacturing experience would be of benefit
Skills & Behavioural Competencies:
- Demonstrates a high level of Technical understanding.
- Drives continuous improvements
- Ability to multi-task
- Proficient at review of EudraLex chapters and CFR 21 parts 210 and 211
- Leading investigations and OOS’s
- Leading GMP and Quality impacting training site wide
- Experience with process and method validation review and equipment qualification
- Implement and review Major change controls and associated Risk Assessments.
- Coordinate and lead customer complaint investigations
- Lead auditor trained
- Provide QA oversight to projects
- Provide training to level 1 officers and interns
- Risk assessments and regulatory compliance implementation and interpretation.
- Perform Gap Assessments between current procedures and related guidance’s
- Work to assigned goals
For a confidential discussion and more information on the role, please contact Josh Barnes on 021 4911066 or email firstname.lastname@example.org