Provides operational, scientific expertise and compliance knowledge support to the Manufacturing Sterile Operations. Responsible for executing manufacturing investigations (QE’s), Corrective Action Preventive Action (CAPA’s),NTR’s, NOE’s, procedures development & revision, and process validation documentation.
Acts as facilitator for the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation.
This incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job functions.
1. Ensures that all QE’s, NTR’s, NOE’s and CAPA’s are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
2. Reviews and provides input to regulatory submissions applicable to area of responsibility.
3. Leads QE’s and CAPA’s trend evaluation.
4. Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
5. Supports establishment of process monitoring parameters and control limits.
6. Supports the assessment of deviations and process monitoring data
7. Monitors and evaluates parameters in existing (on-going) processes to optimize process times / productivity, equipment performance, yields and quality.
to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP’s compliance.
9. Write, evaluate and revise the required manufacturing documentation (i.e. SOP’s, MBR’s, etc.) and may assist in providing training on scientific or technical aspects of the processes.
10. Assists with generation and execution of validation protocols and reports.
11. Participates in regulatory inspection when necessary.
12. Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity).
13. Provides alternatives and recommendations to improve and maximize processes and equipments.
14. Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
15. Promotes and model the BMS Core Behaviors, facilitating teamwork.
16. Supports all site Initiatives and any other assignments based on business needs.
Knowledge / Skill :