Manager Compliance

14+ years

Not Disclosed

Halol

10 Jan. 5, 2025

Job Description

Job Type: Full Time Education: MSc / B.Pharm / M.pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager Compliance - Quality
Date: December 25, 2024
Location: Halol 1 - Quality, Sun Pharmaceutical Industries Ltd

Job Summary:
Sun Pharmaceutical Industries Ltd is seeking an experienced Manager Compliance to handle both internal and external quality audits, oversee inspection processes, manage compliance actions arising from regulatory inspections, and monitor corrective actions. The ideal candidate should have a strong background in microbial and sterile processing with 14+ years of experience in compliance management within the pharmaceutical industry. The role will involve coordinating with various teams during audits, ensuring timely responses, and tracking CAPA (Corrective and Preventive Actions) implementation.

Key Responsibilities:

Audit and Inspection Management:

Handle internal and external quality audits, ensuring all regulatory standards are met.
Coordinate the pre-inspection process with cross-functional teams (CFT) to prepare thoroughly for audits.
Lead the inspection team and Subject Matter Experts (SMEs) during regulatory inspections, ensuring the inspection process runs smoothly.
Draft and facilitate inspection responses and track the timely implementation of CAPA (Corrective and Preventive Actions) post-inspection.

Compliance Action Tracking:

Monitor and track the progress of compliance actions that arise due to regulatory inspections, internal audits, and customer audits.
Oversee self-inspections to ensure ongoing compliance and readiness for external audits.
Perform gap assessments of newly or updated regulatory guidelines, ensuring that any deficiencies are identified and rectified.

Microbial and Sterile Processing:

Possess and apply knowledge or work experience in microbial and sterile processing within the compliance and audit framework.

Education and Experience:

MSc, B.Pharm, or M.Pharm in a relevant field (such as Pharmaceutical Sciences, Microbiology, etc.).
A minimum of 14 years of experience in pharmaceutical compliance, with specific experience in microbial and sterile processing.
Extensive experience in managing audits and ensuring adherence to regulatory compliance standards.

Key Skills and Attributes:

Audit Management: Proficient in handling both internal and external audits, ensuring that regulatory requirements and quality standards are met.
Regulatory Knowledge: Strong understanding of regulatory guidelines and quality assurance principles, especially in microbial and sterile processing.
Leadership and Coordination: Ability to manage teams and coordinate across different functions to ensure compliance actions are implemented.
CAPA Management: Experience in drafting and monitoring CAPA timelines to address audit findings and regulatory observations.
Gap Analysis: Ability to perform gap assessments and identify areas for improvement in line with updated regulatory requirements.
Attention to Detail: Strong focus on compliance and quality management, ensuring all documentation and actions are handled with precision.

This role is essential for ensuring that Sun Pharmaceutical Industries Ltd. maintains its high standards of quality assurance and remains compliant with regulatory requirements. The Manager Compliance will play a critical role in the success of audits, regulatory inspections, and continuous improvement in the company's compliance practices.

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Manager Compliance

Job Description

Key Responsibilities:

Audit and Inspection Management:

Compliance Action Tracking:

Microbial and Sterile Processing:

Education and Experience:

Key Skills and Attributes:

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