What are the responsibilities and job description for the Supervisor, Quality Validations position at PCI Pharma Services?
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 disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
Work near moving mechanical parts for up to 1/4 of the day.
The noise level in the work environment is typically, quiet.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
College Level Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
High Standard of Report Writing
Preferred:
Experience with quality validation documents including, but not limited to, statements, plans, protocols, test results, modifications, deviations, procedures, work instructions, job aids.
Experience with computer systems, HVAC systems and utilities.
Ability to work on multiple projects at the same time
Ability to meet aggressive timelines
Good interpersonal/teamwork skills
Effective communication skills (verbal and written form)
Good documentation practices
Effective at leading project teams and interfacing with customers and operations personnel
Must possess and demonstrate motivational and leadership qualities
Must possess excellent problem solving and analytical skills
Must be well organized along with being detail and multi-task oriented, formal project management skills desired
Knowledge and experience in cGMPs, FDA regulations and other international regulatory agency regulations
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VETERANS
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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.