VICE PRESIDENT - QUALITY ASSURANCE

Recruiter
Bristol Laboratories Ltd
Location
Luton, UK
Salary
Competitive
Posted
11 Sep 2019
Closes
17 Sep 2019
Ref
1259620963
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
VICE PRESIDENT - QUALITY ASSURANCE

Vice President - QA

£60,000 - £65,000 per annum Luton, Bedfordshire & Peterlee, Durham

Bristol Laboratories Ltd is one of the leading pharmaceutical companies in the United Kingdom engaged in the development, manufacturing, marketing and distribution of generic medicines, as well as formulation brands. We have state of the art manufacturing facility in Luton & Peterlee.

We are currently looking for a Vice President- Quality Assurance in Luton as well as Peterlee.

Job Accountabilities will include:
  • To provide leadership to the Quality Assurance team to ensure effective , compliant and safe management of the QA function and its staff
  • Ensure that appropriate staff training and development is in place to assure competency in role to achieve objectives.
  • Actively pursue opportunities for quality improvement and promote a strong culture of Quality Awareness within the organisation.
  • Preparation, review, approval and implementation of centralized procedures for Quality Management Systems. • Scheduling, implementation and monitoring of Quality Audits. • Management of Product Quality Reviews. • Management of Market Complaints. • OOS management. • Vendor Management- Audits, compliance monitoring and periodic monitoring. • Contract manufacturing and testing: Auditing & Approval Agreements Periodic Monitoring • Centralized Analytical Specifications for raw materials, packaging materials, intermediates and Finished Product. • APR management- Schedule, Implementation, review and approval • Management and control of: New Product introduction Management information system- Scheduling, implementation and maintenance. • To be part of the steering committee and Quality Assurance review committee of the company. • Management of quality system updates and integration of Bristol Labs affiliates
  • To implement Product Quality System (PQS) through the organization to support manufacturing and packing operations.
  • To organize and provide technical training throughout the organisation.
  • To implement GLP and GMP in the organization.
  • Manage MHRA and other regulatory bodies.
  • To investigate any quality issues (Example: deviations, complaints, incidents, OOS) and implement any corrective and preventive action.
  • To support regulatory for its smooth functioning (including management of the change control system)
  • Manage and participate in self inspection and audit programme.
  • To coordinate the CAPA system
  • To provide any technical support and co-ordination wherever required to ensure new products are introduced to site without any delay being caused by QA.
  • Communicate with other areas to ensure the business in kept up to date with developments.
  • To introduce and co-ordinate management of Key Performance Indicators (KPIs) for quality related measures and align with rest of business
  • Ensure PQRS are generated as per SOP
  • Maintain a thorough understanding of regulatory requirement and updates and communicate to rest of Bristol Laboratories
  • Ensuring GEMBAs in all areas.

You will be working with a strong team of experienced professionals and will receive continuous learning & development opportunities.

Knowledge & Skills Required:
  • Academic achievement to Post graduate Degree level in a Science based discipline.
  • Management experience in Quality Assurance in Pharmaceutical industry.
  • Firm understanding of Quality Assurance activities /cGMP/cGLP and QMS procedures in a pharmaceutical manufacturing unit as well as in warehousing and distribution.
  • Should have sound knowledge on computer validation.

The last date for application of this job vacancy will be 9th October 2019.

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