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Job Descrption

MAIN PURPOSE

RDi are seeking a skilled and experienced quality specialist to oversee the quality activities in related to medical device products with a focus on pharmaceutical quality and GDP (Good Distribution Practice) supporting the setup and ongoing compliance to the MHRA WDA (Wholesale Distribution Authorisation).

Duties and Responsibilities

Quality Management System - Develop, implement, and maintain the QMS in accordance with GDP, and relevant pharmaceutical regulations.

Ensure continuous improvement of the QMS, to processes, procedures relevant to GDP as well as other business applicable standards.

Regulatory Compliance - Stay informed on the latest requirements and guidelines from the MHRA and other authorities in relation to GDP.

Product Quality Assurance - Oversee the operational processes involved in the management of pharmaceutical products, including incoming inspection, in process check and pharmaceutical product release.

Conduct risk assessments and FMEA to... identify quality issues and develop mitigation strategies in relation to pharmaceutical products.

Supplier Management - Review and assessment of suppliers in relation to GDP, audit where applicable. Perform and complete supplier performance ratings and risk ratings.

Audit Management - Perform internal audits to ensure compliance with the requirements of GDP.

Manage as part of team and external assessment and audits for GDP.

Training and Development - Perform training to relevant departments on the documentation and processes in relation to GDP.

Non-Conformance and CAPA Management - Manage and investigate and non-conformance or deviations, complaints in relation to GDP and medicinal products.

Develop and implement Corrective Actions (CAPA) in response to quality issues.

Quality Metrics and Reports - Establish and monitor metric s in relation to the GDP processes and quality.

COMPETENCY REQUIREMENTS

· A positive, pro-active can-do attitude.

· Communicate clearly with strong and adaptable interpersonal skills.

· Authority to reject product and documentation that does not meet requirements.

· Honest, trustworthy and reliable – demonstrate good integrity.

· Time management and ability to prioritise tasks to ensure customer and business needs are met.

· Have strong attention to detail with the ability to take a holistic view when appropriate.

· Remain calm and upbeat even in difficult circumstances, always looking for continuous improvement.

· Self-motivated and able to perform as part of a team, supporting their colleagues when required.

· Strong verbal and written communication skills.

· Working knowledge MS Office and Outlook.

· Follow Company Quality, Environmental and Health & Safety Procedures.

Notice to Agency and Search Firm Representatives - RDi is not accepting unsolicited CV's from agencies and/or search firms for this job posting. CV's submitted to any RDi employee by a third-party agency and/or search firm without a valid written and signed search agreement, will become the sole property of RDi. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral.

Job Type: Full-time

Schedule:
• Monday to Friday

Work Location: Hybrid remote in Croydon

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