Manages activities and supervises support personnel associated with document control to provide documentation support to all areas of the plant for SOP's, specifications and batch records.
Provides site leadership and coordination of Change Control processes to assure conformance with B&L requirements and maintenance of records associated with change control activities. Works closely with all site and regulatory personnel and management in effecting complete, thorough and regulatory compliant implementation of desired changes.
Develops and coordinates training programs and procedures to effectively assure personnel are sufficiently trained to perform required job functions. Creates a training environment that promotes employee training and utilizes resources to assure successful training programs.
1. Manage Change Control activities for both domestic and international markets and oversees the Change Review Board.
2.Manage Document Control Department resources in performance of Document Control related activities.
3. Provides support for documentation input to Annual Products Reviews and Annual Reports for regulatory submissions.
4.Interfaces with site functions and business functions in developing and implementing process improvements through interactions including Project Meetings, Process Improvements and Management Review.
5. Responsible for human and financial resources within thedepartment, including the periodic evaluation of performance against plans and standards.
6. Responsible for the GMP, ISO, and EHS procedure awareness and compliance within the respective area.
7. Representative for QA at customer and regulatory audits.
8.Oversee site Training processes and programs to assure site compliance with B&L and regulatory standards including developing training programs.
9.Assure departmental compliance of applicable FDA, OSHA (safety),ISO, etc. regulations and support compliance awareness through tracking and communication of key metric data.
Bachelor’s Degree with a major in Engineering or Biological/Chemical Science.
10 years in pharmaceutical or medical device FDA GMP environment with 5+ years of supervisory experience. Experience with international regulatory agencies highly desirable.
Thorough knowledge of pharmaceutical manufacturing/controls and Good Manufacturing Practices.