Qa Head

20+ years

Not Disclosed

Remote

10 Jan. 1, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: QA Head
Date: Jan 1, 2025
Location: [Insert Location]
Company: [Insert Company Name]

Role: QA Head

Job Summary:

The QA Head is responsible for overseeing all aspects of Quality Assurance at the site, including In-process QA, Quality Management Systems, Analytical QA, QA-Validation, and Documentation. This role executes Quality Assurance goals and strategies aligned with compliance, product quality management objectives, and regulatory requirements. The QA Head is accountable for the quality of products manufactured and dispositioned at the site.

The position also involves proactively assessing quality issues, ensuring compliance with QA regulatory requirements, monitoring quality assurance metrics, and maintaining readiness for internal and regulatory agency audits.

Responsibilities:

Define and execute operational strategy and roadmap for Quality Assurance management at the site, in line with Sun Pharma compliance, product quality objectives, and regulatory requirements.
Manage site Quality Assurance activities and allocate necessary resources for smooth QA operations.
Oversee batch disposition of products.
Provide leadership and expertise to meet Quality Assurance goals at the site.
Identify and implement solutions for improving site QA systems and processes.
Coach and develop direct and indirect reports, providing performance feedback and development opportunities.
Manage performance issues in a consistent and timely manner.
Ensure adequate resources are available to maintain GXP compliance.
Maintain site readiness for regulatory agency inspections and internal audits.
Execute Quality Management Reviews, monitor performance, and identify areas for improvement.
Ensure compliance with regulatory requirements for product, process, and release procedures, releasing safe and effective drug products as per cGMP standards.
Design and implement quality-related SOPs, Policies, Standards, and QA systems at the site.
Facilitate internal and regulatory audits, addressing audit findings comprehensively.
Monitor industry trends/issues and identify opportunities to improve site QA management.
Authorize written procedures, documents, and amendments as required.
Ensure training of department personnel is carried out as per requirements.
Manage change control and quality risk management processes, ensuring adherence to procedures and approvals.

Job Requirements:

Educational Qualification:

B.Pharm / M.Pharm

Experience:

20+ years of experience in Quality Assurance

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Qa Head

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