Qa Head

20+ years

Not Disclosed

India Remote

20 Feb. 11, 2025

Job Description

Job Type: Full Time Remote 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

Job Summary:

The QA Head is responsible for managing all aspects of Quality Assurance (QA) at the site, including In-process QA, Quality Management System (QMS), Analytical QA, QA-Validation, and Documentation. This role ensures that Quality Assurance goals and strategies align with regulatory requirements, and product quality management objectives. The QA Head is accountable for the quality of products manufactured and dispositioned at the site, proactively assessing quality issues and ensuring compliance with QA regulatory requirements in manufacturing operations. The position also ensures that the site is always prepared for internal and regulatory agency audits and inspections.

Key Responsibilities:

Strategic Management:

Define operational strategy and roadmap for Quality Assurance management at the site.
Execute site Quality Assurance goals and strategy in alignment with Sun Pharma's compliance, product quality management objectives, and regulatory requirements.
Manage all aspects of the site's QA activities and resources to ensure smooth operation.

Leadership and Team Development:

Provide leadership to the QA team, ensuring achievement of business and functional Quality Assurance goals.
Coach and develop both direct and indirect reports, providing ongoing feedback, performance reviews, and training opportunities.
Address performance issues in a timely and consistent manner.

Compliance and Quality Control:

Ensure compliance with GXP (Good Practice) requirements, including regulatory and internal audit readiness.
Oversee the batch disposition process for products manufactured at the site.
Ensure all quality-related SOPs, Policies, and Standards are designed, implemented, and maintained at the site.
Ensure all market complaints, failures, deviations, and corrective/preventive actions are addressed according to set timelines.
Monitor and ensure compliance with regulatory requirements for product, process, and release procedures.
Guarantee the release of safe and effective drug products in line with cGMP requirements.

Audit and Inspection Management:

Lead and facilitate internal and regulatory agency audits at the site.
Ensure that audit findings are understood, assessed, and appropriately addressed site-wide.
Ensure the site is always audit-ready for regulatory agency inspections.

Continuous Improvement:

Monitor industry trends and identify opportunities for improving site Quality Assurance systems and processes.
Manage the change control and quality risk management process at the site, ensuring adherence to all requirements and providing approvals as necessary.
Facilitate the required training of department personnel to ensure continued compliance with regulations.

Quality Management and Documentation:

Oversee the execution of Quality Management Reviews and performance monitoring for continuous improvement.
Ensure the proper validation and qualification processes are followed as per procedure.
Ensure that written procedures and documents, including amendments, are authorized appropriately.

Job Requirements:

Educational Qualification:

Required: B.Pharm / M.Pharm

Experience:

Minimum Experience: 20+ years of experience in the pharmaceutical industry, with significant experience in quality assurance roles.

Skills and Competencies:

In-depth knowledge of GXP requirements, regulatory compliance, and cGMP guidelines.
Proven experience in managing quality management systems and leading QA teams.
Strong leadership, coaching, and team development skills.
Excellent communication and interpersonal skills, with the ability to collaborate across functions.
Ability to manage multiple priorities, solve complex problems, and lead continuous improvement initiatives.
Proficiency in quality risk management and change control processes.

Why Join Us:

Impact: Lead the QA function and play a crucial role in ensuring the quality of pharmaceutical products.
Growth: Opportunity to contribute to the continuous improvement of site processes and the overall quality management system.
Innovation: Work with cutting-edge practices in quality assurance and regulatory compliance within the pharmaceutical industry.

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