Validation Officer -South West London
Pharmaceuticals - £40,000 - £45,000
Our client is a well-established healthcare business that currently manufactures a number of brand name products worldwide.
With the recent growth of their Validation Team our client is looking for a Validation Officer to help ensure that all production process, equipment, utilities, cleaning, and computer systems used for GxP purposes are qualified and are fit for their intended use in accordance with cGMP guidelines and GAMP.
To lead, and execute, individual process, equipment, and cleaning validation projects assigned by the Validation Manager and as per the site validation master plan (SVMP).
To help comply with all policies, procedures, templates, and regulatory requirements required to support validation activities.
Key Responsibilities / Duties
- Lead, design, write, execute, and report process, cleaning, and equipment validation activities in accordance with cGMP guidelines.
- Support computer systems validation projects where applicable.
- Liaise with key stakeholders in the Operations, QA, and Technical teams to ensure that validation activities are effectively communicated and agreed.
- Prepare risk assessments of the current status with respect to processes, cleaning, or equipment, and lead the implementation of appropriate CAPA to minimize the risks identified.
- Assist the Operations and Technical teams with the introduction of new equipment, products, or processes from a validation perspective and ensure timely planning and support to their implementation.
- Assist in the periodic update of the SVMP
- Provide regular project status updates and key performance measures to the Validation Manager as required
- Ensure that a high and consistent standard of record keeping is maintained for all validation activities.
- Assist with regulatory inspections, to provide clear explanations for validation activities, protocols, and reports.
- Write standard operating procedures (SOP) and work instructions (WI) where required.
- Assist in deviation investigations and problem-solving activities.
Qualifications / Experience
- Degree of equivalent in a scientific discipline or qualified by experience.
- Minimum of 3 years validation experience in a cGMP environment.
- Good understanding of cGMP validation regulations and guidelines including Eudralex Volume 4 Annex 15 and ICH
- Proven project management experience.
- Pharmaceutical or regulated healthcare/ FMCG experience.
- Knowledge of pharmaceutical equipment and computer systems requirements.
- Good influencing skills with personnel at all levels in the company.
- Experienced in leading and delivering multiple validation projects simultaneously
If you are interested in applying for this role please click apply now!
Harris Lord is acting as an employment agency for this role.
Contact: Josh Hemsley
Keywords: Keywords: validation, IQ, OQ, PQ, process validation, equipment validation, GMP, cGMP, GDA, validation engineering, engineer,
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