Validations Contractor - GMP Quality Assurance
Validations Contractor - GMP Quality Assurance
Posted on :
27-10-2024
Employer Active
The job posting is outdated and position may be filled
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
For further inquiries regarding the following opportunity please contact one of our Talent Specialists
Infant at
Meenakshi at
Infant at
Meenakshi at
Title: Validations Contractor GMP Quality Assurance
Location: Research Triangle Park NC
Duration: 12 Months
Location: Research Triangle Park NC
Duration: 12 Months
Description:
The Validations Contractor GMP Quality Assurance reporting to the Director GMP Quality Assurance will be responsible for assisting in the management of Clients Quality Management System (QMS) and will strongly support Clients Culture of Quality. This role will assure corporate compliance with applicable GMP national international and state regulations. This position will be based at our headquarters facility in RTP NC with domestic travel (less than 15% of the time) expected.
The Validations Contractor GMP Quality Assurance reporting to the Director GMP Quality Assurance will be responsible for assisting in the management of Clients Quality Management System (QMS) and will strongly support Clients Culture of Quality. This role will assure corporate compliance with applicable GMP national international and state regulations. This position will be based at our headquarters facility in RTP NC with domestic travel (less than 15% of the time) expected.
Job Responsibilities
Work alongside department customers on development implementation and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.
Provide timely quality support and thorough reviews and approvals of various records including but not limited to Change Controls; SOPs; analytical method equipment and computer system qualification and validation plans protocols and summary reports; batch records; QC data; nonconformities and Corrective Action/Preventive Action (CAPAs).
Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.
Report on applicable key metrics to drive continuous improvement in compliance.
Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.
Maintain Quality Systems in support of Clients QMS and GMPs including:
o Review and approve SOP drafts and revisions.
o Process change controls.
o Support equipment and computer system qualification and validation activities and vendor management program.
Communicate project status to stakeholders and escalate issues in a timely manner.
Work alongside department customers on development implementation and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.
Provide timely quality support and thorough reviews and approvals of various records including but not limited to Change Controls; SOPs; analytical method equipment and computer system qualification and validation plans protocols and summary reports; batch records; QC data; nonconformities and Corrective Action/Preventive Action (CAPAs).
Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.
Report on applicable key metrics to drive continuous improvement in compliance.
Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.
Maintain Quality Systems in support of Clients QMS and GMPs including:
o Review and approve SOP drafts and revisions.
o Process change controls.
o Support equipment and computer system qualification and validation activities and vendor management program.
Communicate project status to stakeholders and escalate issues in a timely manner.
Requirements:
Bachelors degree in a scientific field.
5 years of experience in pharmaceutical biotech or biologics GMP regulated manufacturing environment with 3 years in Quality and/or Manufacturing.
Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards and where appropriate other regulatory authority standards.
Ability to author review and interpret Standard Operating Procedures (SOPs).
Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic flexible and constructive manner.
Strong attention to detail highly organized and the ability to multitask in a fastpaced highly interactive environment.
Ability to manage workload effectively in order to meet project timelines.
Excellent verbal and written communication skills and the ability to effectively collaborate with peers including scientific/technical colleagues.
Proficiency in Microsoft Office Suite (Word Excel PowerPoint).
Bachelors degree in a scientific field.
5 years of experience in pharmaceutical biotech or biologics GMP regulated manufacturing environment with 3 years in Quality and/or Manufacturing.
Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards and where appropriate other regulatory authority standards.
Ability to author review and interpret Standard Operating Procedures (SOPs).
Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic flexible and constructive manner.
Strong attention to detail highly organized and the ability to multitask in a fastpaced highly interactive environment.
Ability to manage workload effectively in order to meet project timelines.
Excellent verbal and written communication skills and the ability to effectively collaborate with peers including scientific/technical colleagues.
Proficiency in Microsoft Office Suite (Word Excel PowerPoint).
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
