Department: Pharmaceutical Packaging
Office: Clinton, MA
Location: Clinton, MA
Job Grade: IC4
Develops and implements validation and qualification policies, procedures and protocols. Reviews and analyzes protocol data to determine if requirements are met. Prepares and submits protocol reports for internal and customer review. Recommends corrective action where necessary and develops master validation plans. Assist with all activities for handling Finished Product from receiving to shipping as well as assessing and ensuring compliance through training, auditing and corrective and preventive actions. Responsible for ensuring that all departments/divisions within a plant where devices are assembled/packaged with drug/biologic products or diagnostic reagents (Finished Product) comply with applicable regulations and CGMP practices of the US Food and Drug Administration, EU and other global competent authorities.
Education And/or Experience
B.S. Degree in a science; or 5+ years of Pharmaceutical industry experience.
6+ years experience in validation or qualification in healthcare or other regulated field
Essential Duties and Responsibilities:(include the following. Other duties may be assigned)
Develops validation and qualification protocols and tracks execution of protocols in support of project timelines.
Resolves discrepancies and deviations during protocol execution.
Coordinates and manages the validation and qualification strategy for equipment and processes.
Maintains and administrates the change control program for critical equipment and systems.
Evaluates, makes recommendations and implements improvements to the validation and qualification program as part of continual improvement activities.
Develops and maintains validation and qualification system level documents including master validation plans, policies and procedures.
Support all company safety and quality programs and initiatives.
Ensures that suppliers and contractors are appropriately approved
Assists in providing training to ensure that personnel engaged in the receipt, manufacture, processing, packing and holding of Finished Product and their components have the education, training and experience to perform their assigned functions
Ensures that components, WIP, and Finished Product are inspected according to all requirements, batch records are reviewed and approved by Quality prior to release and that if errors have occurred, the errors have been fully investigated
Ensures that Quality reviews and approves all documents that impact the identity, strength, quality and purity of the Finished Product and that documentation is in compliance with HC GBU, Plant, and relevant regulatory requirements
Participates in FDA audits and provides input to any 483 responses
Participates in FinPack customer audits and provides input to Nypro response to any findings
Audits or manages additional auditors to assess compliance to Finished Product, Nypro and regulatory requirements
Assists Quality Engineers, Engineering and Operations staff in developing quality plans, inspection work instructions and procedures, equipment operation documents and any other documents required for batch records
Participates in corrective action investigations associated with Finished Product and ensures that true root cause and effective corrective action is enacted
Assists in the resolution of FinPack customer complaints with the assistance of assigned quality, operations, and engineering personnel
Strong Technical Writing Skills as well as Good Communication Skills
Strong Team Player
Experience with handling of control substances a plus