The QC Compliance Specialist position will be responsible for leading compliance related activities, such as investigations, change controls, risk assessments and CAPA's in QC. This position involves interaction with cross-functional /cross site where required and a close relationship with Quality Assurance.
Key factors in the function of this position are flexibility, good organization, having excellent time management, solid tracking and follow up, and being self-motivated to make continual progress with minimal supervision.
Responsibilities will include:
- Leading/supporting root cause investigations to support QC OOS/OOT and deviations, ensuring all activities are performed in a timely manner and in compliance with procedures and regulatory requirements.
- Ensuring corrective & preventative actions are appropriate, implemented as planned, and has the intended effectiveness.
- Identifying recurring events and trends. Ensuring appropriate actions are taken.
- Developing a metrics and reporting system for QC compliance issues and escalation process. Reporting metrics for AQR, CPV, executive management and quality management reviews.
- Leading and managing change controls to support QC commercial operations, where required.
- Support an internal compliance and Data Integrity programme within the QC department.
- Lead the self-inspection programme and inspection readiness efforts for QC department. Support Gilead global inspection programme for CMO and CTL where required.
- Interact with the QC staff regularly to answer questions related to GMPs and help champion a compliant work environment with a continuous improvement focus.
- Work with the QC team to develop robust training programs.
- Prepare and deliver general quality related training programs and compliance initiatives both local and global cross site initiative's/alignment activities.
- Participate in internal/external audits, as required.
- Lead or participate in QC and/or cross functional or global projects.
- Update/approve documents to ensure compliance with cGMP, GMP and Pharmacopoeia.
- Representative in Gilead Global Teams, Pharmacopoeia, Alignment or inter site collaborations.
As QC Compliance Specialist you will have:
- Requires at a minimum BS degree in a scientific discipline.
- 2+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
- Expertise in Trackwise or Veeva vault an advantage.
- Data integrity and Annex 11 computerised systems knowledge
- Registration/Regulatory experience
- Experience leading and implementing projects and Project Management
- Ability to speak, present data, and defend approaches in front of a variety of audiences.
- Organizational skills to contribute to department and cross-functional projects
- Familiarity with FDA & European GMP's and regulatory requirements, other guidelines, and recommendations.
- Operational Excellence, problem solving and Lean.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.