Duties and Responsibilities

1) Project Responsibility: [25%]

• Lead and execute projects such as technology transfers, scale-up manufacturing, process optimization, process and packaging validation, equipment qualifications,

and cleaning validation to meet critical project deadlines;

• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing;

2) Commercial/Compliance Responsibilities: [30%]

• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive and corrective actions as necessary;
• Execute process and facility equipment qualification activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, and out of specification calibrations;
• Perform cleaning validation activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, and cross contamination program maintenance;

3) Commercial/ Project Responsibilities: [30%]

• Conduct commercial production support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, and hold time studies;
• Independently develop and/or execute experimental designs and approaches to resolve complex technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques;
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, and change control

4) Communication Responsibilities: [5%]

• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution;

5) Project and Safety Compliance Responsibilities: [10%]

• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department;
• Directly interact with PEL Healthcare clients;

• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.