We are working with a pharmaceutical manufacturing company who is seeking a Senior Quality Specialist/CQV to support their quality systems and validation activities.
This company's core mission is to drive growth and spark innovation within the scientific community, helping a mutitude of pharmaceutical companies solve some of the world's most urgent healthcare problems.
Key Responsibilities:
- Independently define and lead Quality/CSV Project.
- Provide technical guidance and leadership to lesser experienced team members.
- Complete review of previous assessments completed by third parties and established/drafted client documentation to drive development of a complete Validation Inventory List and Project Plan.
- Lead project in its entirety
- Develop and maintain a project plan/Gantt with deliverables and resource assignments.
- Maintain an inventory list of documents and their status throughout the project.
- Development and Delivery of Artifacts
- Oversee additional team members and drive delivery of high-quality documentation
- Delivery of new documents and/or update current documents and align to Client documentation format per defined Validation Inventory List and Project Timeline.
Key Requirements:
- Travel to site in Grove City, Ohio 5 to 7 times based upon project demands.
- Demonstrated project leadership capabilities.
- Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
- Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client's organization.
- Ability to mentor and guide lesser experienced team members.
- Ability to communicate effectively with clients.
- Proven ability to identify areas of business expansion and report to the management team for follow-up.
- Intermediate Microsoft Project capabilities.
- Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485 Quality system standards for medical devices or ISO 9001 Quality Management Systems and IS014971 Risk Management Systems required.
Please apply in if you feel that you'd make a good fit for this role given your background and qualifications.
