Work Flexibility: Hybrid or Onsite

What you will do

Independently processing results of PFA assessments.

Initiate, organize and coordinate global containment actions

Ensure that data is documented for the different sites.

Together with the PFA specialist create a communication to affected parties.

Provide necessary information to regulatory compliance team for reporting.

Presenting PFA/commercial hold relevant processes and cases during audits

Preparing weekly, monthly and quarterly Commercial Hold relevant statistics

Performing training of colleagues and managers by procedural changes

What you need

Required Skills:

B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of working on PFAs, and Commercial Holds.

Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability.

Poses the ability to lead colleagues in other departments to perform the necessary actions for a timely Containment action

Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.

Sound knowledge on complaint handling process of medical devices will be an added advantage

Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have)

Preferred Skills:

Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment.

Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.

Travel Percentage: 20%