Manager, Validation; Quality Assurance - NY

Company: Curia
Location: Decatur
Posted on: March 20, 2023

Job Description:

Manager, Validation

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Validation Manager is an essential part of Quality's management team. The Validation Manager will assist in management of the daily activities of the Validation Department. The Validation Manager will be responsible for overseeing the validation activities of the site, review of applicable change controls for impact to validation criteria as well as maintenance activities associated with validated equipment and systems. The Validation Manager will revise the essential validation documents including the Validation Master Plan(s).

The Validation Manager will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs. This position leads the department in actions related to new product introduction. This position is also responsible for managing the activities of the Validation Department in terms of equipment re-qualification schedules and associated activities during facility shutdowns, and ensuring the plant is in a ready state to manufacture product after shutdown activities have been completed.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

Directly supervises employees in the Validations Department. This role carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Essential job duties

• Responsible for providing leadership for the Validation Department at the facility
  
• Ensure change controls, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP)
  
• Coordinate validations with section supervisors to ensure timeliness with minimal disruption of production schedules
  
• Review and write validation protocols, final reports, and summaries of work for release of equipment tested
  
• Perform the usual duties of a manager such as develop annual goals and objectives for department; develop, implement and manage annual operating budget; approve expenditures; monitor staffing; address employment issues; ensure compliance with regulations and policies; and manage the overall functions of the Validation area
  
• Serve as validation liaison between the site and customers or regulatory agencies during facility audits and provide audit support by presenting validation activities
  
• Provide leadership and guidance to staff in the performance of their duties. Manage performance objectives, scheduling, hiring, performance evaluation, etc.
  
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance
  
• Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report
  
• Coordinate and prioritize validation activities at the facility
  
• Write, update, and maintain pertinent Validation Master Plans for the facility
  
• Develop annual goals and objectives for department and manage the overall functions of the Validation area
  
• Approve validation protocols for all equipment/systems
  
• Review and approve cleaning validation, facilities cleaning validation, packaging system validation, and computer-related system Validation Master Plans
  
• Review and approve validation protocols for computer related systems (as needed), environmental monitoring (if applicable), and process validations
  
• Participate in the review of changes made under the Change Control System from a validation perspective
  
• Provide validation oversight to facility, utility and equipment upgrades
  
• Provide validation input to technology transfers
  
• Author, review, or approve impact assessments prepared by the Validation Department for change controls
  
• Departmental Housekeeping:
  
• Review and revise SOPs as needed for approval
  
• Directly understand and implement safety procedures and cGMP
  
• Develop and execute plans for growing individuals within the Validation Group
  
• Provide plant management with data and information appropriate to reduce potential for regulatory action and assist in site productivity management
  
• Provide information to customers on validation activities and improvement plans, as needed
  
  Education, experience, certification and licensures
  
• Education: BS/BA in Engineering, Chemistry, or Life Sciences and
  
• Manager: minimum 7 years of experience in Quality and Validation of pharmaceutical, API or relevant fields and at least 3- 5 years process validation or equipment qualification experience
  
• Experience leading, supervising, or managing others required
  
  Knowledge, skills and abilities
  
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  
• Ability to write reports, business correspondence, and procedure manuals
  
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
  
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
  
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  
• Knowledge of database; Internet, spreadsheet, and word processing software
  
  All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
  
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Keywords: Curia, Decatur , Manager, Validation; Quality Assurance - NY, Executive , Decatur, Illinois