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Apulki Healthcare Thane
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Quality & Compliance Executive

Quality & Compliance Executive

Apulki Healthcare Thane

1 - 3 years

|

2 - 4 Lacs

Posted:5 hours ago| Platform:

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Skills Required

audit compliance internal audit process quality compliance iso compliance management process compliance regulatory process audit regulatory compliance auditing sebi

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Support compliance activities for ISO 9001, ISO 27001, USFDA, CE Marking, CMMI, and other healthcare software regulations.

Assist in preparing and maintaining documentation for CDSCO and NABH HIMS requirements.
Coordinate internal and external audits, ensuring findings are tracked and closed on time.
Ensure products, processes, and documentation meet applicable regulatory and certification standards.

Quality Management & Process Support

Maintain and update the Quality Management System (QMS) in line with organizational and regulatory needs.
Draft, review, and update Standard Operating Procedures (SOPs) and process documents.
Support corrective and preventive actions (CAPA) and help identify process improvements.

Documentation & Reporting

Maintain centralized, audit-ready documentation for all certifications.
Prepare required reports, checklists, and records for audits, reviews, and compliance submissions.
Work closely with cross-functional teams to ensure documentation accuracy and timely updates.

Training & Internal Coordination

Assist in conducting periodic internal trainings on SOPs, security standards, and compliance requirements.
Promote adherence to quality processes across teams through regular coordination and follow-ups.

Qualifications

Bachelors degree in Life Sciences, Engineering, Quality Management, Healthcare, or related fields.

Preferred candidate profile

Working knowledge of:

ISO 9001 / ISO 27001
USFDA 21 CFR Part 11
CE Marking
CMMI (DEV/SVC)
CDSCO medical device guidelines
NABH HIMS
Strong documentation and audit coordination skills.
Good communication, attention to detail, and ability to multitask.

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Apulki Healthcare Thane

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