QA Compliance

6 days ago

Bengaluru Karnataka, India Alcon Full time

Summary of the Position:
Execute routine and nonroutine compliance activities to include Change Control, Audit Management, Quality Metrics, Document management and review of regulatory documentation such as Annual Product Quality Reviews. Also responsible to provide technical expertise on compliance matters during various cross functional team meetings or interactions and drive quality improvement projects.

Essential Functions
- Duties are listed in order of greatest importance. Other responsibilities may be assigned._
- Essential Functions_- Support of external audit activities including and not limited to ensuring site preparedness by site walkthroughs, site personnel training and coaching, coordination of effective CAPA and effectiveness check plan and followup to ensure timely CAPA closure.- 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.-
- Perform compliance activities as per schedule and per standards/SOPs.- Prepare and take ownership of compliance SOPs.- Participate in investigation, root cause analysis, CAPA management and risk management activities as required.- Keep work areas clean and free of hazards or dangerous conditions Follow all safety regulations, and promote positive safety behaviors, Report unsafe work conditions and/or behaviors and maintain audit readiness.- Support internal audit (selfinspection) 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.

Minimum Education/Experience

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

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