Company: Advanced Clinical Recruitment Ltd
Location: London + Flexibility
Closing Date: 16 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary + Package
I am currently working with a very interesting and exciting CRO who are currently moving through a very exciting time in their development. They are currently looking for a Quality Assurance Officer to join the group, reporting into the new Quality Assurance Manager. The Officer will be integral to the group, as they will be tasking with the conduct of audits, management of the quality system and working closely with clients to ensure compliance. There will be many opportunities for progression.
Role and Responsibilities
Take ownership, develop and maintain and continually improve business processes and procedures.
To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD expectations; e.g., EU Directives, CFR 21 Parts 11 and 312, along with guidelines and other applicable external legislation and standards e.g., ISO 9001, ISO 13485, ISO 14971, MDD 93/42 EEC and Data Protection legislation.
Provide GCP, MDD and regulatory expertise, guidance and training for the company.
Implementation and maintenance of all aspects of the Quality System and SOP life cycle including (but not limited to) process development, review, implementation, training, monitoring of process compliance e.g., via evaluation of SOP deviations, revision and decommissioning of SOPs.
Updating, maintaining and improving the Quality manual and process content on our document management system (built on the web application Twiki).
Implementation and maintenance of the QA and Compliance Strategy including (but not limited to);
Defining, maintaining and periodically reviewing the strategy for effectiveness.
Take ownership of the internal and key suppliers auditing schedule and process.
Host and manage audits by potential and on-going customers and regulatory inspections.
Support implementation and oversight of Corrective Actions and / or Preventive Actions and other issues that may impact quality.
Identify those areas of quality processes that need to be improved and propose new ways to improve quality at IXICO while maintaining those processes and systems that are working.
Ensuring that the quality system is established, implemented, maintained and monitored in accordance with relevant standards.
Monthly reporting to senior management of quality and regulatory metrics and issues; e.g., non-conformities and progress in resolving these through monthly reporting.
To prepare and conduct with top management, reviews of IXICO's QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness.
Skills and Experience
Extensive experience as a quality professional in the pharmaceutical regulatory environment, and has held Quality / Regulatory positions for more than five years.
Experience within both large pharmaceutical companies and CROs is desirable.
Extensive experience of definition and maintenance of Quality Management Systems, audit planning and management and the clinical trials process.
Excellent understanding of GCP and clinical trials regulation and compliance requirements.
Experience of ISO 9001 / ISO 13485 Quality Management Systems.
Experience of managing external (client) audits and regulatory inspections.
Ability to work in a small company environment and influence at all levels in the organisation.
Ability and experience to drive the IXICO Quality and Regulatory Compliance agenda.
Experience in submissions to regulators and interaction with regulators is desirable.
Strong organisational skills and the ability to multi-task with a goal-oriented approach whilst maintaining attention to detail.
Ability to prioritise and manage tasks/requests for support and sometimes competing demands.
A strong team-player. Proactive and personable.
An excellent communicator able to influence others to bring about quality improvements.
Highly IT literate, methodical, meticulous and a completer finisher.
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor, Manager, GCP Manager, London, Remote, Flexible, Central
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