Clinical QA Compliance Manager

2 days ago

Bengaluru, Karnataka, India Alcon Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Supports Clinical Development, Clinical Operations, Clinical Evaluations, Medical
Affairs and Medical Safety including Post Market Surveillance activities for all Alcon
franchises, to maximize standardization and compliance.

• Informs senior management of the need for corrective and preventive actions with a
key advisory role in the development of action plans and monitoring of effectiveness of
action plans as a result of internal GXP audits and those submitted to Health
Authorities as a result of inspections.

• 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.
Identifies and collaborates in establishing appropriate measures to assure communication,
management and remediation of compliance issues involving Clinical Development/
Clinical Evaluations, Medical Safety and Medical Affairs and other associated
departments such as Global Vigilance, Complaint Intake, Regulatory Affairs, Vendor
Management, etc. Trends, interprets, and presents compliance data (e.g., deviations or
deficiency letters for all franchises) according to worldwide regulatory requirements and
specifically EUMDR and Alcon standards

• Authors or reviews & approves documentation including but not limited to:
Reviewing, commenting and/or approving documents associated with regulatory
submissions, notes to file, templates, template revisions, aggregate reports
(CEP/CERs, PMCF, PMSP, PSURs), policies, QSPs and SOPs.

• Provides SME consultation and assists in education and training as well as
interpretation of global regulations and guidelines (e.g. EUMDR, FDA, GCP, GLP,
GMP, MDR, ISO Stds., GMP, Vigilance, Deviation Management, etc.).

• Provides guidance, review, and approval of associated deviations (NCI, & CAPAs)
If necessary, lead and support the

• investigation of deviations and other quality issues detected from any source.
Accountable for CAPA follow up and verification activity jointly with Clinical
Development.

• Provides support for audit & inspection preparation, conduct and remediation as
needed, for both national and local inspections (e.g., FDA, MEA, MHRA, Notified Body
etc.). Provides QA support to Supplier Evaluation Teams as needed and conducts GXP
audits as assigned.

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