| Quality Validation Specialist || Hybrid || Raleigh, NC || Relocation Open at Raleigh, North Carolina, USA |
| Email: [email protected] |
| From: Gaurav Gaur, DMS VISIONS INC [email protected] Reply to: [email protected] Hi, Hope you are doing well, Please find the job description given below and let me know your interest. Position: Quality Validation Specialist || Hybrid || Raleigh, NC Location: Monday and Friday will be onsite in Raleigh, NC and Tue, Wed and Thursday will be Remote (Relocation is fine) Duration: 12 Month Project Visa: Any JOB DESCRIPTION: The position will support planning and adherence to plans for any qualification and validations required for the commercial product pipeline and the transfer of INDV-6001 to the Indivior FCP and US finished product facilities for phase III and commercial production. The specialist will generate the required Indivior QMS records to manage and track the transfer of product to new facilities. The records include change control, risk assessments, CAPA, qualification and validation protocols and reports. The specialist will be expected to technically interpret, write, and review controlled documents and reports, review data produced by others and participate in quality operational investigations. Approve all approved commercial product validation protocols and reports to support the commercial product validation lifecycle. Executes change control tasks for validation projects. Validation planning and execution surge support for Raleigh. Execute and Review QMS records deviations/CC/CAPA for all Indivior product portfolio validation projects. SCOPE / DIMENSIONS OF ROLE Coordinate and communicate the move, tech transfer, qualification and validation of the INDV-6001 API and Drug Product Manufacture process to Indivior FCP and Curia Burlington. Track and raise awareness when delays are encountered for tech transfer activities to the FCP and US finished product manufacturing sites. The scope of the role includes the completion of all related documentation for the move, technical transfer, testing, qualification, and validation. Role will support other validation projects as needed, including commercial lifecycle validation support and surge support for Raleigh site validations as required. RESPONSIBILITIES / ACCOUNTABILITIES Independently or with a team reviews the technical transfer plan, test plans, change controls, qualification, and validation documents to ensure adherence to EU Annex 15 and 21CFR part 211 requirements. The role is responsible for making sure the facility, utilities are qualified and validated to the level at the FCP and US finished product manufacturing sites. Provides tech transfer support to Indivior in developing and closing out TT protocols and reports, change controls, qualification and validation protocols and reports as applicable. Participates in 3rd party validation planning meetings and communicates key info to Indivior stakeholders. PROFESSIONAL QUALIFICATIONS/ EXPERIENCE Required: Bachelor's Degree in Life Sciences or Engineering with 3 to 5 years' experience in a regulated GMP manufacturing or equivalent understanding of applicable regulatory requirements GMP documentation writing and review Knowledge of the pharmaceutical industry and Quality Systems or experience within a GxP discipline (GPV, GCLP, GMP, GDP) required. Proficient in validation and qualification, risk assessments for equipment, facility, process. Knowledge of EU Annex 15 Validation and Qualification requirements. Preferred: Extensive knowledge of aseptic manufacturing requirements and procedures for drug products, as applicable to focus of position. Extensive exposure to cGMP environment Knowledge of tech transfer and process validation requirements. Knowledge of regulatory requirements for drug products including FDA, EMEA, Health Canada and other markets. PERSONAL ATTRIBUTES Ability to work in a team and cross-functionally when required. Good communication skills, written and oral. Developing influential skills in areas with no direct reporting authority. Ability to work independently to deliver outputs and through others as required. Attention to detail. Adept IT skills and ability to learn quickly. Proficient in English. However, fluency in other languages is advantageous. If you are interested, please share your updated resume and suggest the best number & time to connect with you Thanks & Regards, Gaurav Gaur Email: [email protected] | Phone : 972-645-9280 LinkedIn: https://www.linkedin.com/in/gaurav-gaur-hr/ DMS Vision ,INC 4645 Avon Lane, Suite 210 Frisco, TX 75033 Keywords: information technology North Carolina Texas Quality Validation Specialist || Hybrid || Raleigh, NC || Relocation Open [email protected] |
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| Wed Oct 23 03:45:00 UTC 2024 |