Qualification: Bachelor’s Degree
- 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.