QA Associate- Gcp

2 weeks ago


London, United Kingdom Richmond Pharmacology Full time

Richmond Pharmacology’s continued growth is resulting in additional hires across all departments. We are hiring a Quality Assurance Associate to assist in ensuring that Richmond Pharmacology is fully compliant with all regulations and can deliver high quality data for all of our clinical studies.

**Title: QA Associate**

**Location: London Bridge, SE1**

**Salary: £25 - 28k + Benefits**

The QA Associate will assist the QA team in assuring quality throughout the Company. You will be promoting continual improvement processes to ensure all systems and procedures undertaken within Richmond Pharmacology Limited are compliant with ICH-GCP Guidelines, and other applicable regulatory requirements.

**Key Responsibilities include**:

- Assist QA team in assuring Richmond Pharmacology continues to meet applicable quality standards by communicating any observations or deviations identified during day-to-day activities.
- Assist in ensuring Non-Conformances (NCs) / Incident Reports (IRs) are tracked, assessed, reviewed, and approved, using the Quality Management System (QMS), according to SOP timelines.
- Assist in ensuring Quality Documents (QDs) are tracked, assessed, reviewed, approved, and revised using the QMS, according to SOP timelines, including performing a quality check prior to finalisation.
- Assist with organisation of internal audits, including vendor audits, in accordance with the audit schedule defined by QA management.
- Assist with ensuring CAPAs following Internal, including vendor, and External audits are distributed, responded to, assessed, and followed up until closure, using the QMS.
- Assist with the preparation and conduct of External audits (Sponsor audits and Inspections) including organising the agenda, booking meeting rooms, organising hospitality, assisting with document requests and ensuring closing meeting minutes are taken and distributed, etc.
- Assist with preparation, review, and formatting of presentation slides for Quality Council Meetings, ensuring minutes are taken, reviewed, and actions distributed, etc.
- Take minutes at QA meetings and ensuring actions are communicated and followed up accordingly.
- Ensure the promotion and advancement of quality awareness and culture throughout Richmond Pharmacology, including organizing QA Induction training, GCP training, GDocP training, etc. to all staff.
- Other administrative tasks, as designated by QA team.
- To work to QDs, laws, guidelines, regulations and rules, and ensure all relevant training is up to date.

**Qualifications & Experience**
- Experience in clinical trials with an understanding of processes and regulatory demands of the industry
- Knowledge of Quality Assurance within the Pharmaceutical industry required.
- Knowledge of Quality Management Systems within the Pharmaceutical industry required.
- Knowledge of ICH-GCP, and GMP guidelines preferred.

If you would like to register your interest in the role, please submit a current copy of your CV via the link. You will also be asked for basic contact details and salary expectations.


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