Job description 

Summary of Position:
Execute compliance activities to include Change Control, Audit Management, Quality Metrics, Document management and review of regulatory documentation such as Annual Product Quality Reviews.

Key Responsibilities:

Support and coordinate documentation requests by external customers and regulatory.

Coordinate the effective implementation and support of Change Control Management (PPC, ECN etc.).

Control and management of document lifecycle in plant document control system (e.g Veeva).

Perform various compliance activities that ensure required quality and safety standards are met for our products.

Support of external audit activities including and not limited to ensuring site preparedness through coordination and follow-up to ensure timely training completion, coordination of effective CAPA and effectiveness check plan and follow-up to ensure timely CAPA closure.

Perform compliance activities as per schedule and per standards/SOPs.

Responsible for documentation of investigations, root cause analysis, CAPA management and risk management activities as required.

Support internal audit (self inspection) to assure compliance with global medical device and pharmaceutical regulations, local procedures, and corporate policies / procedures.

Ensures compliance to audit schedule and timelines as per procedures.

Cooperate and support coworkers to enhance overall capability of the organization.

Participate in problem solving and troubleshooting of issues.

Key Requirements/Minimum Qualifications:

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

Performs other duties as assigned

Complies with all policies and standard.