Manager, Validation – 1st Shift (Lynchburg, VA)

TITLE :

• Manager, Validation – 1st Shift DEPARTMENT : Quality OCCUPATIONAL SUMMARY : Manage the functions for validation of product and cleaning of in-house manufacturing and packaging systems.
• This includes commissioning, engineering studies, IQ / OQ / PQ, process validation and cleaning validation.
• Serve as management representing Validation during internal and external audits.
• Lead technical evaluation on process investigation and validation troubleshooting.
• Develop company validation standards that meet current industry standards for pharmaceuticals & train the key stakeholders.
• Accountabilities
• Manage all company validation functions related to manufacturing, raw materials, packaging, testing, and distribution of our products, including writing protocols and final reports, reviewing testing methods, and analysis of data.
• Lead validation staff and resources provide training and coaching.
• Provide oversight, writing and execution of commissioning documents and Engineering studies and IQ / OQ / PQ, process validation and cleaning validation.
• Development and execution of a validation program that complies with industry standards and applicable government regulations.
• Provide technical assessment and support for validation and investigations and effectively develop & write risk assessments.
• Moderate direct impact on profitability results from maintaining proper adherence to validation and stability guidelines.
• Responsibilities
• Manage the development and writing of validation policies, procedures and protocols in validation program.
• Manage the IQ / OQ / PQ, cleaning and utilities validation.

Work closely with Engineering on new equipment specifications and engineering changes as related to process and cleaning validation.

ACCOUNTABILITY :

No Sponsorship :