- Title: Regulatory Compliance Associate
- Code: RCI-22936-1
- Location: Rocky Mount North Carolina (NC) 27804
- Posted Date: 09/14/2021
- Duration: 18 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
Remote with some On-Site (candidate will need flexibility)
Act as core team member responsible for coordinating and identifying Regulatory and Compliance Remediation activity plans related to product transfer.
Basic Qualifications and Skills needed
- Degree in Science or Engineering based discipline, laboratory experience a plus
- Familiarity with Change Management requirements, and Processes related to Compendial methods remediation, validation/qualification for manufacturing, and Quality and technical risk management tools.
- Relevant Drug Product Technical Experience related to processing and manufacturing pharmaceutical products.
- Excellent Communication and presentation skills.
- Relevant experience with manufacturing operations for Sterile Injectable Drug Products.
- Relevant skills to gathering data from multiple sources and summarizing into simple, well organized documents
- Ability to be flexible and manage multiple deadlines
- Work independent to meet deadlines within team goals
- Documentum, Doc-U Sign and Track-wise experience preferred
- BS Degree is required