Are you an experienced Clinical Operations professional? Do you have experience writing SOP's in a clinical / quality related environment? If so, this could be the perfect opportunity for you!
We are recruiting for a Quality Operations Specialist to join a leading multinational biopharmaceutical client based in Berkshire.
The successful candidate will support the Head of Process Quality Excellence in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.
Candidates will need experience and focus on GCP regulations and guidance.
This is a contract position, inside IR35, offered initially for 12 months on a hybrid basis. Minimum 2 days a week on site preferably Tues & Thurs but this can be flexible if needed.
Responsibilities:
* Support the Head with quality and compliance infrastructure development, assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed.
* Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for ICH, GCP and relevant local and international regulations and to ensure inspection readiness.
* Lead and drive inspection readiness activities across functions working closely with the relevant inspection teams.
* Participate in audit and inspection planning with global quality.
* Represent or ensure representation including preparation during audits/inspections / on-site by internal and external parties.
* Support staff with audit/inspection responses, where required.
Requirements:
* 8+ years of pharmaceutical experience, preferably in a global quality assurance or a clinical development setting.
* In-depth experience of GCP including hands on experience in global GCP audits and/or inspections.
* 2+ years of experience in SOP writing essential.