Snr Quality Systems Specialist

A leading pharmaceutical client is searching for a Snr Quality Systems Specialist to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

The Quality Systems Specialist will be responsible for ensuring that operations carried out within the Quality Systems section are completed in accordance with the requirements of the company Quality System and Standard Operating Procedures.

Preparing, reviewing and maintaining quality policies and procedures associated with Product Quality Review, Quality Agreements, Complaints, Training, Deviations, Parallel Imports, Risk Management, Qualification and Validation, Training, Standard Operating Procedures, Internal and External Audits and Approved Supplier activities to form part of the company's Quality System.

Job Responsibilties:

• Support the Maintenance of the EML Quality System in compliance with the requirements of EU GMP Guidelines, WHO requirements and FDA CFR parts 210, 211 and CFR part 11
• Generate Quality Systems procedures to meet company corporate, pharmaceutical industry and GMP expectations.
• Provide technical knowledge to support the EML Change Control System
• Provide technical knowledge on regulatory variations and maintenance of marketing authorization dossier updates
• To support the ongoing operation, maintenance and implementation of improvements to TrackWise processes and systems to meet EML's needs.
• Participate and lead customer and regulatory audits of EML (internal and external).
• Lead audits of external suppliers of product and services for EML and EMEA business companies.
• To support Quality Systems training of EML staff, as required.
• To provide day to day support to other members of the Quality Systems team, as appropriate.
• To provide training and mentoring to other members of the Quality Systems team or EML personnel.
• Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
• To support the management of the Regional Quality System procedures and processes.
• Generate KPI, Management Review and Quality Management Systems reports.
• To deputise for the Quality Systems Manager, when appropriate.
• To perform any appropriate duties at the request of the Quality Systems Manager.

Skills and Requirements:

• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Extensive knowledge of Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Computer literate e.g. Word, Excel and PowerPoint
• Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations
• Diplomatic, self-motivating,
• Problem solving and decision-making capabilities.
• Professional behaviour and self-awareness
• Good communication skills.
• Good presentation skills
• Ability to work effectively within a Team
• Effective time management

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.