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Project Manager, QA Manager

Work Experience

Validation Specialist
Project manager for the site laboratory equipment validation programme. Responsible for the co-ordination of team members in delivering the validation exercise to the agreed deadlines. Ensure compliance to FDA standards. Key responsibilities include: Risk assessment; generation and execution of Installation and Operational protocols, URS, FDS and technical validation reports.

Project Manager
Responsible for managing and co-ordinating the transfer of sterile products to a third party manufacturer. Key responsibilities included: compilation of technical file; selection of manufacturer; costing negotiations; Preparation and development of project plan and budget; preparation and agreement of regulatory strategy.

European Project Manager, R&D
Worked with European marketing to ensure that the R&D strategy and project portfolio was aligned with Global & European markets. Produced a business case that justified the value of a potential new project. Identified and created key project team. Gained business approval for a new project. Managed the project until launch stocks were available on the shelf or until project was terminated. Responsible for the development and management of clinical studies. Technical responsibilities included: manufacturing transfers; Third party licence acquisition and distribution agreements; third party business support units; New product development and identify defensive strategies for existing products.

Operational Quality Officer
Ensured compliance with GMP directives for FDA pre-approval inspection. Prepared Annual Product Reviews for actives. Approved manufacturing and validation documentation for compliance with required GMP and regulatory standards. Developed monitoring processes for: process deviations, process investigations, and internal audits. Conducted compliance audits for primary actives. Reviewed existing practices and policies to identify potential improvements.

Project Manager
Seconded to the USA to set-up new manufacturing facility and ensure compliance with OSHA, EPA and DOT. Established and managed project including implementation schedules, resource requirements and integration efforts. Developed manufacturing processes for new ink technologies. Successfully managed and delivered multiple development projects to timescales. Developed and implemented new laboratory processes and procedures. Responsible for site health and safety programme.

Quality Specialist
Developed and managed the Valve Assembly Quality Control and Quality Engineering functions. Determined COSHH assessments for all site laboratory work. Responsible for ensuring site compliance with FDA manufacturing practices and conducting customer FDA related audits. Established new career structure within department. Developed and implemented site validation master plan. Responsible for reviewing SOPs and validation protocols. Developed and managed product development integration processes between manufacturing, process and development teams. Introduced the cGMP regulations as site team leader.

Senior Chemist
Designed and implemented new efficient QC processes for inks. Performed high profile role in team to resolve major field problems with global ink. Established and developed U.K. quality control team for ink business. Promoted to USA to establish quality control function. Established and participated in technical project teams with major dye supplier to resolve critical quality and technical issues. Developed good supplier relationships, to ensure supply of quality raw materials. Supervised quality control personnel. Promoted within fourteen months of transferring to USA. Maintained departmental budget within forecast. Flew to England at short notice, successfully resolved manufacturing issues, establishing reliability and robustness in manufacturing processes.

Shift Chemist
Planned and managed QC testing of all samples. Resolved and managed scheduling and quality issues.

Education

June 2001 Reading University: Qualified Person – Pharmaceutical Microbiology
Qualified Person – Quality Management Systems

BSc (Hons.)Applied Chemistry.

Postgraduate Diploma in Manufacturing Management & Technology

Skills

•11 years quality and manufacturing experience
•4 years pharmaceutical experience
•4 years Project Management experience
•Experienced in FDA GMP/GLP and European directives
•Audits to FDA compliance requirements
•Management of laboratories working to GLP standards
•Understanding of ICH GCP guidelines
•Management and organisation of control room for external audits.
•Supervision of graduates and technicians (managed two groups nineteen direct reports)
•Experienced in following areas of validation:
•IQ, OQ and PQ
•Test Validation
•Treatment of Out of specification results – non-conformance
•Experienced in OHSA , EPA and COSHH safety requirements
•Development and management of clinical studies
•Review of Part II submissions
•Process improvements
•Management and development of ISO9002 quality system
•Quality improvements
•Statistical Process Control
•Project Management – using following methodologies
•Prince 2
•Critical Path method
•PERT analysis
•Cost control
•Analytical problem solving skills
•Budget control
•Training personnel in quality and safety procedures
•Auditing of suppliers
•Computer proficiency – Microsoft word; Microsoft Excel; Microsoft PowerPoint and Microsoft Projects 98
•Experienced in customer and supplier liaisons
•Development of manufacturing processes
•Good interpersonal and leadership skills
•Strong communicator
•Proven experience in delivering projects to agreed timescales
• Full clean driving licence

Languages

English

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