Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process
Job Summary
Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process.
Responsible for overseeing the Non Conformance Report (NRs) and Corrective action and preventive action (CAPA) and Audit Observations.
The company is committed to providing an inclusive work environment where each person is considered as an individual, respecting diversity and dignity, and recognizing merit.
Matching Summary
Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process.
Skills & Requirements
Must-have
Non Conformance Report (NRs)
Corrective action and preventive action (CAPA)
Audit Observations
QSR, GMP and ISO requirements
FDA 21 CFR and global medical device regulations
failure mode analysis techniques
Nice-to-have
leadership and guidance
cross functional, multilevel technical teams
teamwork, initiative, creativity, assertiveness
attention to detail
effective interpersonal skills
Key Requirements
Bachelors Degree required
Minimum of 4 years of experience in NC/CAPA & Audits Observations process