| CSV Specialist :: Raritan, NJ (Onsite from Day-1) at Raritan, New Jersey, USA |
| Email: [email protected] |
| Greeting from Shrive Technologies LLC!! Shrive Technologies LLC is an IT Development & IT Staffing firm with more than a decade of experience in providing IT Staffing Solutions & Services. Our expertise is in sourcing and deploying highly skilled IT Specialist into mainstream and niche technologies to meet clients Temporary, Permanent & SOW project needs. Title: CSV Specialist Location: Raritan, NJ (Onsite from Day-1) Duration : Long Term Mandatory Skills : CSV, 21 CFR part 11, Data integrity, Archiving Job Description 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 Please provide the below details for submission along with Visa copy & Photo ID copy, I94/Passport# Candidate Details Candidate Full Name (As per SSN) Current location (City and State) Open for relocation to work location (Yes/No) Contact/Phone # Address Skype ID Visa Type Visa Validity (Month & Year) /Work Authorization Date of Birth (Month & Year Only) Passport Number SSN( Last 4 Digits) Bachelors details (University /College & Passing year) Masters details (University/College & Passing year) Total IT experience (Years) Onsite [USA/Canada] Experience (Years) Profile Reason for Job Change Availability to join post selection Interview availability (Preferred time slots for next 3 days) -- Thanks & Regards, Naren Email: [email protected] -- To post to this group, send email to [email protected]. Keywords: quality analyst rlang information technology Idaho New Jersey |
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| Tue Sep 12 21:00:00 UTC 2023 |