The Quality Validation Specialist is responsible for the Quality oversight and overall approval of validation and engineering change management activities to support the implementation of the Validation quality program.
Requirements
- 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
- Ability to manage complex projects and multiple projects (5+) simultaneously
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Responsibilities
- Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
- Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
- Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
- Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
- Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
- May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
- May lead, author, or review investigations and implementation of preventive and corrective action
Other
- Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
- Strong verbal and written communication skills
- Solid problem solving and analytical skills
- Solid interpersonal skills, including ability to negotiate/influence without authority
