Csv Specialist

7-10 years

Not Disclosed

Raritan

15 June 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Responsibilities:

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.

Requirements:

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

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Csv Specialist

Job Description

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