- Reference: 42339
- Job Type: Permanent
- Location: Dublin City Centre, Dublin North, Dublin West
- Category: Science, Pharmaceutical & Food
JOB TITLE: QA Compliance Manager
We are seeking a experience QA Manager to work as part of a global compliance Team. Your primary objectives will be to ensure all manufacturing and TPM’s sites meet compliance regulations . You will also be responsible for leading continuous improvement initiatives, global quality projects, compliance initiatives, and risk assessments and remediation activities involving various areas under your regions.
- Provides inspection readiness support to the sites -identification of compliance gaps and risks, and participation in the remediation process.
- Provide on-site support during regulatory inspection, as applicable.
- As part of the Global Compliance team, supports the Pharmaceutical Compliance Excellence Program during coordination and execution of on-site assessments and the identification of remediation plans.
- Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close.
- Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
- Responsible for communication and documentation of internal and external compliance related information.
- 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
- Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
- Represents the sites one Corporate wide initiatives and teams as requested
- 7-10 year’s 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 understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
- 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.
- Bachelor Degree in a relevant scientific/ technical discipline such as Chemistry, Pharmacy, Engineering, Biology, Microbiology,
- Travel will be required.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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