Validation Specialist - Infobahn Softworld : Job Details

Direct message the job poster from Infobahn Softworld Inc

Sr Recruitment Manager at Infobahn Softworld Inc

• Process day-to-day quality events and change control records in TrackWise/COMET system (10%)

• Coordinate documents and procedures in truVault system and any other document management system.(10%)

Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in TrackWise system. Ensure all audit commitments are delivered on time (10%)

Required: BA/BS – Technical / Life Science

Desirable: MA/MS/MBA – Business / Technical /Life Science

Support Quality and Compliance Initiatives from Enterprise Quality and/or Global Business Quality

Essential knowledge and skills

Knowledge

• 5 years' experience in the Pharmaceutical or related industry;

• Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;

• Up-to-date knowledge of DEA regulations

• Experience working in the quality organization.

Skills

• Highly experienced in TrackWise/COMET system, generating query and report, and data analysis with excel spreadsheet

• Results-driven leader who commits to stretch goals and delivers results.

• Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups.

Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and client's more broadly. Experience in dealing with regulatory inspections and inspectional requirements

Core competencies required for this role:

Masters Complexity

Customer/ Marketplace Focus

Enable Skills-Based Hiring No

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing

Referrals increase your chances of interviewing at Infobahn Softworld Inc by 2x

Sign in to set job alerts for “Validation Specialist” roles.

Raritan, NJ $93,463.00-$122,670.00 2 weeks ago

LL02-250724 Validation Specialist for Cell Therapy Facility (NJ)

Cranbury, NJ $50,000.00-$70,000.00 1 week ago

Quality Document Control Specialist (Cosmetics) - 156698

North Brunswick, NJ $30.00-$35.00 1 day ago

Regulatory Affairs Specialist - Quality/Regulatory

Totowa, NJ $60,000.00-$65,000.00 2 weeks ago

Morristown, NJ $77,000.00-$87,000.00 2 days ago

JD Logistics - Warehouse Quality Assurance Specialist

Edgewater Park, NJ $70,000.00-$90,000.00 2 months ago

Somerset, NJ $80,000.00-$82,000.00 3 days ago

Princeton, NJ $72,800.00-$80,100.00 5 days ago

Bridgewater, NJ $73,000.00-$97,200.00 6 days ago

LL01-250724 Cleanroom Facilities & Utilities Validation Specialist (NJ)

Lakewood, NJ $77,000.00-$95,000.00 2 months ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr