- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- Catalent (St. Petersburg, FL)
- … QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The ... Product Manager is responsible for the overall Quality Assurance review and approval of all...and/or equivalent combination of education and experience in the QA pharmaceutical industries. Prior experience working with validation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role ... Overview The QA Manufacturing Excellence Manager role is an...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Aequor (Thousand Oaks, CA)
- …required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of ... knowledge of and experience with processes involved in manufacturing and distribution, QA , QAL, validation , and process development. Strong communication (both… more
- Aequor (Thousand Oaks, CA)
- …by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout Ensure ... regulatory inspections Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining business metric… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to ... the business for guidance and consultancy on system validation . Support computer system audits for review of SDLC and data integrity controls. Review CAPA and… more
- Eisai, Inc (Exton, PA)
- …Operations, facilities in planning changes to the Pilot Plant and LabsPartner with Site QA in the GMP validation of Lab automation.Document GMP documentation as ... and manage high-performing staff, address roadblocks and resource or quality issues.Participate in and/or Lead Continuous Service Improvement processes as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/ QA of CDISC, SDTM domain output in accordance ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Rose International (Newton, MA)
- …work experience will be considered. 7 to 10 years of experience as a Quality Engineer in the medical device industry; QMSR/ MDD/MDR and ISO-13485 experience required ... Notified Body/Regulatory Audit experience; Certified Quality Auditor (CQA) certificate is preferred Must have experience in CAPA, NCMR, Internal/External Audits,… more
- Axelon Services Corporation (Bothell, WA)
- … manager . PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation ... of this spotlight call is to review the Sr. Manager , Data Integrity requisition. Please come prepared with questions...or more years of relevant work experience in pharmaceutical quality operations, quality assurance , … more
- Sunrise System Inc (Devens, MA)
- …Manager Sometimes will interact with departments listed below: Quality Control Manufacturing Operations Manufacturing Engineering Manufacturing Science and ... Job Title: QA Lead Technical Operations, Projects Job ID: 24-02756...Technology (MS&T) Validation Site Engineering Digital Plant Education, Experience, and Qualifications:… more
- Amerant Bank (Miramar, FL)
- …Compliance Risk Assessment, Fair and Responsible Banking, change management and Compliance Quality Assurance ) carried out by second line of defense and ... compliance audits performed by in house staff or an outsourced firm and the validation work related to issues identified in Compliance audits. This role will assist… more
- Sunrise Systems Inc (Bothell, WA)
- PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and ... or more years of relevant work experience in pharmaceutical quality operations, quality assurance , ...validation of automated systems is required. Experience with QA oversight of e-systems for GMP operations is required.… more
- Rose International (San Diego, CA)
- …Center/Data Entry Responsibilities: Membership processing Preparation and validation of information Phones Finance related activitiesQualifying Skills ... Role (With options for remote once all training and QA scores are at Operations Standard and approved by...are at Operations Standard and approved by the Operations Manager )Time off: NO Time off during training or first… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Manager , QA Validation Department: ...analysis process and build improved efficiency. + Manage the validation system from a Quality Assurance ... leading integrated research-based pharmaceutical company. POSITION SUMMARY : The Manager , QA Validation is responsible...Experience : + A 6-10 years of experience in Quality Assurance or Design Assurance … more
- Abbott (Abbott Park, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Validation Manager ** **About Abbott** Abbott is a global healthcare leader, ... heart attacks to blood disorders to infectious diseases and cancers. As the ** Validation Manager ,** you'll be responsible for leading the planning, implementing,… more
- Turner & Townsend (Olive Branch, MS)
- …in the world. **Job Description** **Turner & Townsend** are looking for a **Commissioning Quality / Validation Manager ** to work with our team alongside ... our proactive approach, depth of expertise, integrity, and the quality we deliver. As a result, our people get...group. This role will also work closely with the QA /QC Director. The ideal candidate will be resilient, a… more
- Citigroup (Wilmington, DE)
- Citibank, NA seeks a Model/Analysis/ Validation Senior Manager for its Wilmington, Delaware location. Duties: Conduct analysis and prepare detailed technical ... documentation report for validation , sufficient to meet regulatory guidelines and exceed industry standards. Use SAS to generate portfolio loss forecasts based on… more
