CSV Specialist// Raritan, NJ (Onsite from Day-1) at Raritan, New Jersey, USA |
Email: [email protected] |
CSV Specialist Raritan, NJ (Onsite from Day-1) Position Details Job Location/Client Location (with City & State) Raritan, NJ (Onsite from Day-1) Remote ok (Yes / No) No (Onsite from Day-1) Project Duration 6 Months Project/Billing Start date Asap Buy Rate $6 0/hr max xxxxxxxxxxxxxxxxxx Job Title/Role CSV Specialist Mandatory Skills CSV, 21 CFR part 11, Data integrity, Archiving Client Interview Needed for Selection (Yes / No) Yes Detailed JD (Pl share the Detailed Description, 1 liner JD will not work) 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, CAPAs 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: Bachelors or Masters 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 Negotiation skills Convincing Team player Accuracy Problem solver Pankaj Singh US IT Recruiter m: 669-842-4964 EXT 644 w: www.e-solutionsinc.com e: [email protected] Disclaimer: E-Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability. -- Keywords: quality analyst rlang information technology procedural language New Jersey |
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Tue Oct 31 19:54:00 UTC 2023 |