Responsibility is the creation, planning and approval of validation documents to support the Pilot Plant validation requirements under the direction of a managing supervisor.
- 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.
- Bachelor's degree, preferably in Biology, Chemistry or Engineering
- Prefer 2+ years of overall experience in Manufacturing, Quality or Engineering
- Good verbal and written communication skills.
- Good problem solving and analytical skills
- Good interpersonal relations / communications skills
- Good negotiation skills
- Prefer knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced