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Packaging Coordinators, Inc. Manager, Quality Validation in Rockford, Illinois

Position Title: Manager, Validation

Location: ASSM

Department: Quality Validations

Shift: 1 st

Reporting To: Sr. Director, Quality

Responsible For (Staff): Yes

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Validations Manager is responsible for coordinating and managing all validation efforts included with Cleaning, Facility/Utility, Computer, Equipment and Process Validations at multiple facilities. The Validations Manager is responsible for designing, maintaining and continually improving the validation system. The Validations Manager is responsible for implementation and ongoing improvements of the validation policies, protocols and testing. Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments. Coordinate with other departments to communicate validations and provide resources to implement protocol executions. The Validations Manager assures customer requirements are accurately incorporated into PCI systems and assures validation protocols adhere to cGMP requirements.

  • Manages Validations Supervisor(s), and, as required, other Validations personnel

  • Oversees and manages validation staff to conduct qualification and validation activities for process, equipment, utilities, cleaning, and computer systems. Ensure efficient utilization of staff resources in order to meet project goals and timelines.

  • Manage, identify, hire, and develop staff. Create and maintain employee and organizational development. Oversee proper training, goal setting and effective organizing and assigning of work.

  • Reviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.

  • Manage and develop equipment, process, facility, utility, cleaning, and computer validations program that is in compliance with regulatory and customer expectations, which includes developing and maintaining Validation Master Plan and policy and work practices.

  • Design, maintain and continually improving the validation system in line with current national and international standards. Assist with validation harmonization among sites across the PCI Pharma Services organization.

  • Provide Validation technical expertise and guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Operations and Quality Assurance (QA) functional areas.

  • Develops and administers budgets, schedules and performance requirements and evaluations.

  • Support the change management system for validated equipment, production processes, cleaning, utilities and facilities, and computer systems.

  • Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.

  • Participates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.

  • Participate in Operational Excellence projects as assigned.

  • Assist management in matters of manpower planning, development, reward and recognition initiatives.

  • This position may require overtime and/or weekend work.

  • Knowledge of and adherence to all PCI, cGMP, and GxP policies, procedures, rules.

  • Attendance to work is an essential function of this position.

  • Performs other duties as assigned by Director.

Special Demands:

  • Stationary Position: From 1/2 to 3/4 of the day.

  • Move, Traverse: Up to 1/4 of the day.

  • Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.

  • Install, place, adjust, apply, measure, use, or signal: None.

  • Ascend/Descend or Work Atop: None.

  • Position self (to) or Move (about or to): None.

  • Communicate or exchange information: 3/4 of the day and up.

  • Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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