Compliance Specialist Jobs

Job Title: Quality Compliance Specialist - 6+ Month Contract

:

We are seeking a highly organized and detail-oriented Quality Compliance Specialist to support one of our leading pharmaceutical clients. The successful candidate will work closely and collaboratively with Product Quality Management Leads and various stakeholders across the business to ensure compliance with quality standards and regulations. This role will focus on executing product quality surveillance strategies and supporting the integration of new product acquisitions into post-marketing surveillance.

The ideal candidate will have 0-3 years of experience for an Associate level position, 4-7 years of experience for an Intermediate level position, or 8+ years of experience for a Senior level position.

Responsibilities:

Post Marketing Product Quality Surveillance:

• Obtain and compile required data from internal and external suppliers, manufacturers, and packagers.
• Coordinate APQR review meetings and track elements, ensuring timely completion and resolution of outstanding items.
• Assist in conducting annual/periodic product quality reviews (APQR) according to applicable SOPs.
• Support the implementation and maintenance of effective product quality surveillance systems.
• Review SOPs periodically to ensure compliance with regulations and make recommendations for improvements.

1. Acquisition & Integration and Project Support:

• Facilitate the integration of new products into quality systems, including APQR, product complaint system, and monitoring programs.
• Provide support to quality and cross-functional project teams.

Regulatory Awareness, Inspection Support, and Compliance:

• Contribute to the development and revision of SOPs and other cGMP documentation.
• Support regulatory reporting and submissions as required.
• Stay updated on regulatory actions from MHRA/EMA/FDA/DEA and other relevant agencies.
• Assist in regulatory inspections and notifications related to post-marketing surveillance activities.

Experience & Knowledge:

• Working with patients and health care professionals is important
• Strong knowledge of GMP industry standards and quality systems.
• 0-3 years of experience for Associate level, 4-7 years for Intermediate level, or 8+ years for Senior level positions.
• A minimum of a Bachelor's degree in a relevant scientific/engineering discipline.
• Excellent organizational and time management skills.
• Attention to detail and ability to work with complex data.
• Familiarity with TrackWise and experience with APQR is preferred.
• Strong communication and collaboration skills.

20% of needing to be onsite for now then 40% around October, flexible hours, no weekend work!

*No Employers or C2C Houses*