- Sumitomo Pharma (Raleigh, NC)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- Emerson (Durham, NC)
- …* Experience with regulatory/compliance documentation and procedures * Knowledgeable in FDA validation requirements preferred, including User Requirement and ... Design Specs, Business Process Procedures, Design Reviews, Requirements gathering * Experience with GAMP5 * Knowledge of PMI Project Management framework. * Knowledge of MES systems **Our Culture & Commitment to You** At Emerson, we prioritize a workplace… more
- Parexel (Raleigh, NC)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated...updates, CMC changes). * Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.… more
- Reckitt (Wilson, NC)
- …QMS frameworks. + Ensure documentation adheres to GDP standards and regulatory compliance ( FDA , ICH, ISO); support validation and hygiene design requirements. + ... engineering documentation including layout drawings, URS, material flow maps, and validation protocols. + Conduct regular project meetings to communicate progress,… more
- Actalent (Clayton, NC)
- Job Title: Validation SpecialistJob Description The primary responsibility of this role is to provide and lead validation services required for the successful ... material handling flows across the FFEx site. Responsibilities + Provide validation and technical support through the preparation, execution, data analysis, and… more
- Insight Global (Clayton, NC)
- Job Description We are seeking an experienced Validation Specialist to support a pharmaceutical client in the Raleigh area. This person's primary responsibility will ... be to provide and lead validation services required for the successful delivery of highly...11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents -Demonstrated experience using root-cause… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and ... approval of validation and quality assurance/control documentation. + Assists in the...procedures that relate to process, computer systems, and equipment validation . + Assures compliance with SOPs upon implementation. Investigates… more
- Stantec (Raleigh, NC)
- …the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the ... hear from you. We have two immediate openings in our Buildings Commissioning/ Validation group for an enthusiastic, diligent and experienced Commissioning / … more
- IQVIA (Durham, NC)
- …21 CFR Part 11, Electronic Records - Electronic Signatures; General Principles of Software Validation - Final Guidance for Industry and FDA Staff; Good Automated ... US Homebased **Job Description** Provide global regulatory oversight of validation management as part of the Quality Management System. This oversight includes… more
- J&J Family of Companies (Wilson, NC)
- …and validation execution activities to ensure compliance with GMP, FDA , EMA, and other regulatory requirements. + Support the development and implementation ... procedures through the following duties and responsibilities: + Ensure the site validation program has been developed and maintained in compliance with all… more