Experience

Fresenius Kabi Deutschland GmbH

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Quality Assurance Manager

  • Jun 2019 - Present



Fresenius Kabi

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Officer and Deputy Responsible Person

  • Nov 2010 - May 2019

  Final review of Batch Records prior to QP releaseReview and Approval of Deviation, Change Control and Risk Management documentation Responsible for control of Artwork to ensure Regulatory ComplianceSubject matter expert for packaging and Control of ArtworkDeputy Responsible Person for GDP Final review of Batch Records prior to QP releaseReview and Approval of Deviation, Change Control and Risk Management documentation Responsible for control of Artwork to ensure Regulatory ComplianceSubject matter expert for packaging and Control of ArtworkDeputy Responsible Person for GDP



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Release Officer

  • Nov 2005 - Oct 2010

  Quality review and release of incoming components and materials for sterile and non-sterile clinical trials manufacture and distribution to ensure compliance with company and regulatory requirements. Working with all departments on site in order to prioritise workload and ensure manufacturing and packaging components are released on time in full Extensive liaison with Quality Officers at other Wyeth Research sites to ensure that global clinical supplies are released in order to meet deadlines. Review of both manufacturing and packaging batch records to ensure compliance to GMP and regulatory requirements prior to Qualified Person sign off. Ensuring that clinical supplies deadlines are met. Working with all departments in preparation and final approval of Change Controls. Working with the engineering department to ensure that GMP equipment qualification and validation reports complied with GMP and regulatory requirements.Perform Internal audits for manufacturing, packaging and warehousing departments.Investigating, troubleshooting and rectifying quality issues including providing appropriate CAPAsCollation of site Validation Master Plan and have been a key player in setting up and executing the site decommissioning processAuthor and reviewer of local and global SOPs



Ernest Jackson and Co

• Laboratory Technician / Team Leader

  • Jan 1999 - Jan 2004

  Analysis of medicinal products for a contract manufacturer to in house and customer specifications including major pharmaceutical companies.Lead shift of three analysts undertaking routine analysis and stability testing Responsible for training, assessment and appraisals of staff within my team.Lead role in internal, regulatory authority, customer audits and quality management within the laboratory. Redeveloped and validated several HPLC methods resulting in time and cost saving measures, coordinated the installation and validation of a networked chromatography data system.