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Sr Compliance Specialist - QA

Sr Compliance Specialist - QA

Alcon

0 years

0 Lacs

Bengaluru Karnataka India

Posted:2 days ago| Platform:

Apply

Skills Required

compliance documentation evaluation report support reports metrics data management risk escalation audit remediation recruitment training

Work Mode

On-site

Job Type

Full Time

Job Description

Reviews and approves documentation including but not limited to:
Reviewing, commenting and/or approving documents associated with the Clinical Evaluation Report

in support of EU regulatory submissions or DOC, aggregate reports, PMCF-P,
PMCF-R, PMSP, PMSR, PSURs and SSCP.

Attend project meetings as primary point of contact for Clinical QA. Provide input and feedback

on Clinical Evaluation documentation and clarity on the compliance requirements.

Maintains and tracks CQA review and approval deliverables for each project based on project

plans.

Supports preparation of metrics and trends, interprets and presents compliance data per EUMDR

and Alcon standards

Ensures senior management awareness of compliance issues impacting regulatory acceptability, by

appropriately escalating as per quality risk management. Provides support to relevant functions on
proper identification and escalation of quality related issues.

Provides support for audit preparation, collaborate in remediation as needed, for both national

and local inspections (e.g., TUV Notified Body etc.)

Provides support or assist on other tasks as assigned.

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.Find Jobs for EmployeesFind Jobs for Contingent WorkerAlcon 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.

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Sr Compliance Specialist - QA