QUALITY AND COMPLIANCE MANAGER

Recruiter
QUANTA CONSULTANCY SERVICES LIMITED
Location
Romford
Posted
11 Jul 2018
Closes
15 Jul 2018
Sector
Accountancy
Contract Type
Permanent
Hours
Full Time
Are you a Quality and Compliance Manager looking for a new opportunity in South East of England? If so, Quanta may have the role for you.

Our pharmaceutical client based in Essex are currently looking to add the skills of a Quality Compliance Manager to their team on a permanent basis.

The successful candidate will be responsible for implementing and maintaining their internal systems. They will also act as deputy for the third-party logistics providers and will be named as the site's 'Responsible Person'.

Some of the role's responsibilities would include:
  • Preparing, implementing, and maintaining the quality systems required to support Supplier Qualification and management, Quality Agreements, Technical Agreements and Safety Data Exchange Agreements as Complaints/ADR recording, reconciliation, and the internal/external audit program
  • Supplier Qualification, Quality Agreements, Technical Agreements and Safety Data Exchange Agreements as Complaints/ADR recording, reconciliation, and the internal/external audit program
  • To undertake the responsibilities and duties of the 'Responsible Person' as defined within EU Current Good Distribution Practice
  • To take responsibility for, review and approve those elements of the Pharmaceutical Quality System relating to Supplier Quality Management, including Change Control, Deviation Management, CAPA, Quality Risk Management and the Quality System Review
  • To assist the Quality systems Manager with Complaint Management including Recalls and Falsified Medicines
  • Manage and develop, review and revision of Standard Operating Procedures with assistance from the Head of Quality
  • Assist in the training and implementation of QA procedures for GMP compliance
  • Act as deputy contact for Third Party Logistics providers, including the management of the Quality Review process and the preparation, analysis, and response to key performance indicators
  • Participating in Continuous improvement activities.
  • Possible involvement with PV and Medical Information reconciliation, liaising with Business Development Manager and Department, Regulatory Affairs and MD; communicating information and updates as appropriate
  • Liaising with the Regulatory department when necessary with regards to review and preparation of SDEAs
  • Liaison with internal departments and Company contracted Services such as Medical Affairs and PV
  • Organise the Quality Department/filing/systems and all methods in a secure strict environment with relevant access and updates as necessary.
  • Prepare documentation, in conjunction with other Quality team members, to support Regulatory Inspections and External and Internal Audits.
Requirements:
  • Strong background in Quality Assurance and Compliance Management
  • Auditing experience
  • Knowledge of pharmaceutical operating procedures
  • MHRA experience
  • Validation experience
  • Flexible attitude – willingness to assist where the business requires.

If you think this role could suit you, apply today using the links below!

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This job was originally posted as www.totaljobs.com/job/82285784

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