Regulatory affairs and gdp compliance lead - united kingdom, neasden, london

our client is a pharmaceutical supplier and wholesaler based in neasden, nw london.

they are looking for an experienced regulatory affairs and gdp compliance lead to ensure all company sites are aligned with qms standards, gdp requirements, and company objectives.

regulatory affairs and gdp compliance lead

london, nw10 0ab

28,000 - £35,000 per annum

must have at least 2 years’ experience

please note: applicants must be authorised to work in the uk

about the role

the regulatory affairs and gdp compliance lead will help the company maintain excellence in the delivery of good distribution practice under the direction of responsible person personnel by performing operational duties.

you will support changes, enhancements, and upgrades to the qms and maintain the validated status of the system, as well as provide systems expertise in support of maintaining compliance to gdp, regulatory standards and company policies & procedures.

you will also provide support to regulatory health authority inspections and/or audits by external parties, implement training plans to support end users and new starters alike in usage of the qms and provide data/reports in support of measurement against the company quality objectives and plans.

primary responsibilities

acting as primary point of contact and taking overall responsibility as system owner for quality management system (qms) under supervision of rp.
taking responsibility for the initiation, creation and handling of all quality and regulatory processes such as change control, capa, equipment validations and temperature mapping exercise.
working closely with all sites responsible for maintaining quality and regulatory compliance through all daily operations.
managing staff training at all sites including annual gxp training and company’s sops.
managing mhra recalls and customer complaints.
managing company’s cloud-based temperature monitoring system and handling temperature excursion events at all sites
providing expertise in qms systems functionality and capability including scheduling periodic qmr meetings and internal audit for all sites
managing suppliers and customers compliance checks
review and development of standard operating procedures and forms
supporting compliance through the timely provision of quality data and metrics reporting against company quality objectives and plans.
manage, maintain, administer, and support the general upkeep of the qms
contribution to all aspects of the quality management of the company's activities to grow its value and maintain compliance to gxp, regulatory standards and company policies and procedures.

the ideal candidate

the ideal candidate will leverage his/her experience, have a strong grasp of the need and philosophy of an effective qms, and people skills, to proactively contribute to qms.

this role will require someone who can work within a highly innovative, active, and entrepreneurial environment. you will be able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with qms and regulatory requirements.

the job holder will participate in wholesale distribution activities and therefore must train and understand the requirements of good distribution practices as defined in directive 2001/83/ec and various national legislations (e.g., rules and guidance for pharmaceutical distributors /the green guide).

training will also include specific aspects of product identification and avoidance of falsified medicines entering the supply chain.

experience and qualifications:

a comprehensive understanding of mhra good distribution practices as defined in directive 2001/83/ec and various national legislations (e.g., rules and guidance for pharmaceutical distributors /the green guide)
experience of working in similar position within the pharmaceutical industry for at least 2 years.
able to foster support and influence stakeholders throughout the company.
methodical and accurate approach to practical tasks.
commitment to continuing professional development and training.
trustworthy and understanding of confidentiality issues.
high level of concentration with ability to complete tasks accurately and on time.
strong communication and team working skills.
professional, tactful, and friendly attitude.
ability to work effectively with minimum supervision
experience with microsoft office at an intermediate level (i.e., word, excel, powerpoint outlook).

how to apply for the role:

if you have the skills and experience required for this position, click “apply” today and check your inbox for an email providing more information on how to tailor your application and provide a cover letter or any supporting documents.

you must be authorised to work in the uk. no agencies please.

other suitable skills and experience includes compliance, pharmaceutical, mhra, quality management, qms, gdp

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