Change Controller

OUR NEED:

Our site Change Controller is a key member within our Quality Systems realm. Responsible for compiling technical documentation, assess compliance and verify that control has been maintained through the organization. Maintain a relationship with our regulatory partners, domestic and internationally ensuring support and alignment with product filing.

YOUR DUTIES:

1. Administration of Change Controls and APQRs
2. Sustain efficient and effective change control process to maintain required product compliance.
3. Review and sign off change control documentation. Assess changes and their impact to the current filings based on an understanding of regulatory guidelines and company policies
4. Support Chemistry, Manufacturing, and Controls (CMC) changes made to maintain the lifecycle of the approved drugs.
5. Participate in regulatory actions such as field alerts or product recalls, including mock recalls.
6. Maintain awareness of MHRA/HPRA/EMA/FDA, etc. regulatory actions that may affect company products.
7. Interact with the company's various departments to obtain documentation required for the APQRs.
8. Support regulatory assessments, reporting and submissions to Change Controls and APQRs.
9. Assist in regulatory inspections and post marketing product surveillance activities.
10. When appropriate, assist in regulatory notification or market correction activities
11. Initiate, author, revise or assist in the review of SOPs, and other cGMP documentation including but not limited to CAPAs and Deviations
12. Provide metrics regarding key performance indicators
13. Assist as needed in the preparation of data for internal audits and external audits/ inspections
14. Review technical documents for accuracy and acceptability for use in a new ANDA, NDAs, Amendments, Supplements Annual Reports and other required FDA
15. Quality*Stream System Administrator at the site.

YOUR BACKGROUND: