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(Senior) Clinical Quality Assurance Manager

Website Achieva Group Limited

CQA Manager, Senior CQA Manager

Desired start date: ASAP

Duration: 12 months

An excellent opportunity has arisen to join a leading pharmaceutical company as a (Senior) CQA Manager – GCP.

Responsibilities and Tasks: 

Provide expertise / support for Clinical Trials, working closely with the company and CRO Clinical Trials Team. Support Company / CRO Clinical Trial Teams in staying compliant with regulatory requirements (e.g., answering questions; participating to meeting to discuss GCP issues).

Escalate serious / continuing non-compliance GxP issues as appropriate/necessary Provide / Deliver Training / Presentation.

Organize and/or help with trainings on clinical trial requirements. Organize and/or help presentation on ICH-GCP important topics (e.g., CQA audit finding, GCPinspection).

Contribution in ensuring Quality System documents (e.g., SOP, WIS) creation and management is done in accordance with clinical trial requirements. 

Help/contribute to clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems). Help with trouble shooting for processes and systems GCP Inspection.

Participate in management of GCP inspections (e.g., preparation, follow up) by (international) regulatory authorities.

Facilitate the GCP inspection CAPAs elaboration, approval, and follow-up CQA Audit for CQA manager expected to be also an Auditor. Plan, perform, and report standards ICH-GCP audits (e.g., trial site, vendor, process).

Manage CAPAs elaboration, follow-up and closure.

Required Qualifications and Expertise: 

At least a bachelor’s degree or equivalent education/degree in (life) sciences or healthcare.

Experienced in Clinical Research & Development.

Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices – particularly ICH-GCP.

At least 6 years of experience within pharmaceutical industry/health authority with at least 3 years’experience in Quality Assurance (QA) within the ICH-GCP environment.

Knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource).

Reliable, conscientious, agile/flexible, open-minded.

Very good risk analysis and problem-solving skills.

Very good negotiation skills.

Very good writing, verbal and listening skills.

Ability to work as a team player and independently.

Experience working in international cross-cultural relations.

For Senior CQA manager expected to be also an Auditor as per defined in SOP: ability to travel at least 25% of the time.

For further details, please contact Toni Reda on +44(0)1727 817 630 or email treda@achieva.co.uk

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