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.

JOB FUNCTIONS

Duties are listed in order of greatest importance.  Other responsibilities may be assigned. 

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.

Act as subject matter expert (SME) on Quality topics such as Annual product quality review, Change Control (e.g PPC, ECNs etc.).

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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum Education/Experience

Bachelor’s Degree with 3 o 5 years of experience.

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.