Enable job alerts via email!

Senior Quality Specialist

PSG Global Solutions

Winchester

On-site

GBP 80,000 - 100,000

Full time

30+ days ago

Boost your interview chances

Create a job specific, tailored resume for higher success rate.

An established industry player is seeking a Senior Quality Specialist to ensure quality assurance in the Pharmaceuticals and Medical Products sector. This role involves supporting validation, manufacturing, and testing processes while adhering to regulatory guidelines. The ideal candidate will maintain quality systems and provide critical support in batch release and deviation management. Join a dynamic team dedicated to excellence in the pharmaceutical industry and make a significant impact on clinical trial materials and processes. If you are passionate about quality and compliance, this is the perfect opportunity for you.

Expertise in quality assurance and regulatory compliance in pharmaceuticals.
Experience with validation processes and quality systems.

Support quality assurance for clinical trials and manufacturing processes.
Review protocols and reports for compliance with regulations.

Quality Assurance

Regulatory Compliance

Process Improvement

Bachelor's Degree in Life Sciences

Certification in Quality Management

Validation Software

Quality Management Systems

Description

We're looking for a Senior Quality Specialist, working in the Pharmaceuticals and Medical Products industry in 210 Welsh Pool Road, Exton, Pennsylvania, 19341, United States.

Responsibilities:

Provides quality assurance support of validation, manufacturing, and testing of clinical trials materials and serves as a quality assurance resource for the Pilot Plant staff.
Provides quality support within the Pilot Plant in the execution of key quality systems, including equipment, system, and utility validation, SIP, Autoclave, and ongoing process improvement efforts.
Provides quality support to processes such as batch release, deviation and CAPA management, facility management/maintenance processes, validation, and change management.
Provides review of technical, validation, and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH, and JP regulations/guidance.
Maintains Quality systems while ensuring seamless and efficient efforts are applied to ongoing validation, maintenance, automation, and change management processes while ensuring compliance with established policies and procedures.

Get your free, confidential resume review.

or drag and drop a PDF, DOC, DOCX, ODT, or PAGES file up to 5MB.