Compliance Office

Fresenius Kabi•Grand Island, NY

About The Position

The Compliance Officer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the Production Unit from a FDA and global perspective. This function leads teams and projects to identify and correct cGMP inadequacies and ensure a high-level of compliance and Regulatory Audit readiness. The incumbent provides expertise in Deviation investigations, Complaints, Annual Product Review, and helps maintain the compliance of the CAPA system, as well as, reviewing and approving necessary documentation for regulatory correspondence.

Requirements

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, Pharmacy, etc.
3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
Working knowledge of GMP, EU, and GLP, as well as FDA trends and guidelines
Demonstrated experience in problem solving/trouble shooting
High degree of attention to detail
Candidate must possess strong interpersonal, written, and verbal communication skills.
Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.
Good knowledge of MS Office programs, including Word and Excel

Responsibilities

Serves as the compliance SME for all internal audits and supports external and Regulatory Authority audits
Coordinates the collection of information for all Regulatory Requests and assists in the compliance to commitments made to all Regulatory Authorities
Completes Complaint and Event Investigations, including performing risk assessment, impact to product in the field and field safety, facilitating SME discussions, gathering an analyzing relevant data, performing root cause analysis and CA/PA determination.
Leads internal audit teams to inspect and remediate system and process noncompliance in the plant.
Responsible for the Site Master File
Supports compilation of Annual Product Quality Reviews
Ensures that deadlines are maintained for all project types and that extensions are properly justified and documented to maintain compliance.
Maintaining site information for global databases
Any other task as directed or requested by management or site leadership.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.