Supervisor, Quality Validations

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Quality Validation Supervisor is responsible for planning and coordinating daily validation efforts for the qualification of: pharmaceutical packaging, computer systems/applications and, facility and utility systems/equipment. Each Validation Supervisor manages a team of 3 to 10 Validation Analysts, provides technical expertise and guidance to internal/external entities and performs quality review of validation documents with the highest of quality standards.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Coordinates validation efforts between the Validation, Operations, Engineering, Facilities Engineering, Information Technology, Maintenance, Business Unit, and Quality Assurance departments.

Oversees and manages team to conduct qualification and validation activities.

Oversees team training, goal setting and effective organizing and assigning of work.

Reviews and approves quality validation documents including, but not limited to, statements, plans, protocols, test scripts, test results, temperature mapping, modifications, and deviations.

Ensures completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.

Serves as validation expert to other departments, with customers, in meetings and conference calls.

Participates in customer/regulatory audits, visits, and conference calls. Effectively communicates project goals and progress.

Determines level of validation impact for product, software/hardware and equipment changes, and reviews/approves change controls. Analyzes and resolves work problems, or assists staff in resolving work issues.

Manages electronic time and attendance records. Initiates or suggests plans to motivate staff to achieve project deadlines. Suggests and implements changes to increase efficiency.

Assists in matters of manpower planning, development, reward and recognition. Assists in developing and maintaining department work instructions and job aids. Confers with Human Resources to resolve grievances. Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.

Attendance to work is an essential function of this position. May be required to complete and pass training courses such as "Documentation Boot Camp" and "Train the Trainer" as applicable. May be required to become primary contact as needed for validation activities and managing expectations. Performs other duties as assigned.

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

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

Move, Traverse: From 1/4 to 1/2 of the day.

Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.

Install, place, adjust, apply, measure, use, or signal: From 1/4 to 1/2 of the day.

Ascend/Descend or Work Atop: Up to 1/4 of the day.

Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.

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

Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.
This position may have the following special vision requirements.

Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception

Ability to focus No Special Vision Requirements

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with... For full info follow application link.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.