Regulatory Compliance Specialist
5 days ago
The Regulatory Compliance Specialist will be responsible for supporting the Engineering Department in a GMP environment. This role ensures that objectives are effectively achieved, consistent with client requirements to ensure compliance, safety, and reliable supply to customers.
Main Responsibilities:
- Direct and lead deviations, out of tolerance conditions, and unexpected results, conducting failure analysis, root cause determination, and implementing corrective actions.
- Preparation and analysis of Engineering metrics reports to trend for improved operational efficiencies.
- Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWIs, training documents, JSAs, PMs, and change controls.
- Accountable for leading investigation analysis, identifying true root cause, identifying gaps, and actions to close gaps. Collaborate with Engineering colleagues and other departments, particularly IPT, Quality, EHS, and Technical Engineering in completion of tasks.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned.
- Support Audit Readiness activities.
- The role has an element of hybrid work; initially, would be looking for a minimum of 4 days onsite – this could move to 3 days on site after 9 months or so.
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