Compliance Expert

17 hours ago

Navi Mumbai Mumbai Mumbai City, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000
Job Title: Compliance Specialist

Job Description:

The compliance specialist is responsible for ensuring that all site activities are in accordance with company quality policy and applicable regulatory guidelines. This includes reviewing the compliance level of sites for deficiency responses, preparing master validation protocols, and reporting as per company quality policy and regulatory guidelines.

Accountabilities:

I. Review and provide work plans on received deficiencies to headquarters in order to respond to regulatory authorities in a timely manner.

II. Review master validation protocol and report for timely execution of validation batches and submission of documents to respond to deficiencies.

III. Review annual product quality review reports at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness.

IV. Review and upkeep regulated market technical agreements at sites for execution of batches as per customer requirements.

V. Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at units for smooth execution of new products.

VI. Coordinate with auditors and site teams for regulatory and customer inspections/audits at sites to meet regulatory expectations and acquire GMP approvals.

VII. Prepare final drafts of compliance to audit observations and check whether they are in line with cGMP requirements to avoid regulatory actions and continual improvements.

VIII. Collect, compile, and review raw data for timely submission of MHRA, UK interim update documents to corporate as per agency requirements by tracking interim updates at site levels for risk-based inspection planning.

IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.

X. Execute errorless submissions by reviewing product licenses, all certificates for product registration, and tenders, staff approvals, and other applications to adhere to legal requirements.

XI. Support CDSCO and state FDA inspections to be GMP compliant and obtain product licenses and FDA stall approvals by ensuring cross-functional interactions.

Required Skills and Qualifications:

* Strong understanding of regulatory guidelines and company quality policy
* Excellent communication and coordination skills
* Ability to review and analyze data for compliance
* Proficiency in Microsoft Office tools
* Strong analytical and problem-solving skills

Benefits:

* Opportunity to work in a dynamic and challenging environment
* Collaborative team environment
* Professional growth and development opportunities

Others:

* This position requires regular travel to sites for audits and inspections

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