- Title: Compliance Investigator
- Code: RCI-11761740
- Location: East Hanover New Jersey (NJ) 07936
- Posted Date: 01/13/2021
- Duration: 6 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
Author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. Support technical operations with Controlled Changes.
Your responsibilities will include, but not limited to:
Deviation and Investigation Management:
- Initiate deviations within required timeframes and document immediate actions
- Perform impact assessments
- Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
- Support documentation of experimental plan, execution, and results to support investigations
- Ensure robustness (complete, accurate and defendable) of all critical and major investigations
- Author and execute any experiments or runs to support investigations.
- Work cross-functionally to assess and analyze deviations and investigations to determine impact
- Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.
- Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
Corrective and Preventative Actions:
- Develop and document effective corrective and preventative actions
- Ensure all CAPAs are implemented through GMP systems (e.g. MBR revision, training, CR, etc.) in a timely manner
- Monitor and ensure effectiveness checks of CAPAs are conducted
- Communicate to the production team any training or awareness events to reinforce quality behaviors.
- Develop and initiate Change Requests (CRs)
- Manage all phases of a controlled change
- Ensure that changes are implemented in a timely and compliant manner
Communication and Process Improvements:
- Work with the Engineering/Facility/Metrology and Raw Materials/Supplier Quality/Procurement/Sourcing groups to resolve manufacturing vendor material, manufacturing environment, and equipment related issues.
- Escalate deviations when appropriate according to escalation guidelines. Provide deviations details (root cause and CAPAs) until the escalation is resolved to the global escalation team.
- Quality Events: Owns and manages Quality Events related to GMP manufacturing and or Warehousing
- Communicates, escalates, initiates, and owns trend events under the QE module. Ensure that the required CAPAs are communicated and created in order to eliminate or reduce reoccurrences.
Site Quality and Compliance
- Support the site and global C> during self-inspection, audit/inspection readiness and support the backroom if required.
- Opening of deviations within required timeframe Closing of investigations within required timeframe Effective CAPAs Success rate of internal audits and Health Authorities' inspections.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree, preferred.
- Proven writing skills with technical documents
- Fluent in speaking / writing in English