As an experienced support resource, your role will have reponsibility for leading continuous improvement initiatives, global quality projects, compliance initiatives, and risk assessments and remediation activities
QA Compliance Responsibilities
- Provides inspection readiness support through the identification of compliance gaps and risks, and participation in the remediation process.
- Provides on-site support during regulatory inspection, as applicable, as Front or Back Room resource and Division scribe.
- As part of the Global Audit and Compliance team, supports the Compliance Program through the coordination and execution of on-site internal audits and the identification of remediation plans.
- Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close.
- Responsible for communication and documentation of internal and external compliance related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.
- Responsible for leading continuous improvement initiatives including creation, scoping and implementation.
- Manages assigned global quality projects and compliance initiatives.
- Trains employees on areas of expertise, as requested.
QA Compliance minimum requirements
- Bachelor Degree or equivalent level of education in a relevant scientific/ technical discipline such as Chemistry, Pharmacy, Biology, Microbiology, Engineering or industry experience with sufficient exposure to pharmaceutical industry
- 7-10 year experience in pharmaceutical Industry or government regulatory agency and at least 5 years of GxP experience with responsibility for managing the quality system
- Experience in conducting and handling audits and inspections
- Strong knowledge of relevant regulations for quality systems and compliance.
- General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology
- Capable of analysing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
- Excellent verbal and written communication skills and project management skills.
- Open to International travel up to 40%
option to work 2 days remotely
For a confidential discussion and more information on the role, please contact Tina Egan