Description

• Improve the manufacturing process specifications for the production of new generation heart valves.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.    
• Implement periodic reviews and updates to the company procedures (GSOP) to align with the current standards.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis.
• Author and execute TMV’s on the newly created process production specifications.
• Develop Inspection Method and Test Method Validation (TMV) Protocols and Reports.
• Write and oversee execution of Test Method Validation and perform attribute and variable test method validations (TMV).
• Assure compliance of test methods with SOPs and, where necessary, revise/originate SOPs for methods unique to product.
• Perform Test Method Validation (TMV) for equipment/processes utilizing statistics & gage R&R for analysis.
• Perform GAP Analysis and develop corresponding Remediation plan.
• Work hand in hand with R&D labs/ manufacturing engineers to answer questions related to application and use of quality tools viz. SPC, capability analysis.

Bachelor’s Degree required in Pharmaceutical Science.