Katalyst Healthcares and Life Sciences
CSV Specialist
Katalyst Healthcares and Life Sciences, Raritan, New Jersey, us, 08869
Mandatory Skills: CSV, 21 CFR part 11, Data integrity, Archiving
Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation•Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications).•Manage the release of regulated systems for GxP production use •Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures•Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems•Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards•Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU)•In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits
Minimum Qualifications:•Bachelor's or master's degree in science, computer science, or relevant area•English, fluently spoken and written•Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries•A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV•In-depth knowledge of computerized quality systems•Experience with GMP inspections Competences:•Communicative skills
Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation•Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications).•Manage the release of regulated systems for GxP production use •Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures•Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems•Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards•Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU)•In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits
Minimum Qualifications:•Bachelor's or master's degree in science, computer science, or relevant area•English, fluently spoken and written•Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries•A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV•In-depth knowledge of computerized quality systems•Experience with GMP inspections Competences:•Communicative skills