Site Quality Head

20+ years

Not Disclosed

India

10 Dec. 4, 2024

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

Position Title: Senior Manager - Quality Assurance & Quality Control (QA/QC)
Location: Sun Pharmaceutical Industries Ltd.

Position Summary

The Senior Manager of Quality Assurance & Quality Control (QA/QC) at Sun Pharma is responsible for ensuring the supply of high-quality, GMP-compliant products and defining the operational strategy for quality systems management at the site. This role involves leading and directing the achievement of all site accountabilities for QA, QC, and Stability, and proactively assessing and addressing quality issues. The incumbent will ensure compliance with regulatory requirements and manage quality assurance/control metrics across site manufacturing. They will also ensure the site’s readiness for regulatory agency inspections and internal audits at any given time.

The role requires the individual to ensure compliance with all regulatory requirements, GxP’s, and applicable department programs, including training, documentation, Standard Operating Procedures (SOPs), and Sun Pharma's Global Quality Policies, Standards, and Procedures.

Key Responsibilities

Quality Compliance & Issue Resolution
- Proactively assess and resolve quality issues, ensuring compliance with QA/QC regulatory requirements in manufacturing operations.
- Track quality metrics with site manufacturing management and implement strategies to improve them.
- Design and implement quality-related SOPs, policies, standards, and systems at the site.
Continuous Improvement & Efficiency
- Design and execute continuous improvement initiatives to enhance compliance, efficiency, and cost-effectiveness.
- Ensure adequate resources, including manpower, to maintain compliance with GxP requirements.
Harmonization of Quality Systems
- Facilitate the consistent implementation of quality systems and procedures at the site, aligning them with Global Quality policies and standards.
Complaint & Deviation Management
- Ensure market complaints, failures, and deviations are investigated and corrective and preventive actions are implemented in a timely manner.
Regulatory Readiness & Audits
- Ensure the site is always ready for regulatory agency inspections and internal audits.
- Oversee the appropriate implementation of corrective actions based on audit observations.
Industry Trends & Site Improvement
- Monitor industry trends and internal issues to identify opportunities for improving site quality management and processes.
Regulatory & Compliance Oversight
- Ensure compliance with regulatory requirements for product release procedures and processes.
- Manage site quality budgets, track expenditures, and ensure efficient resource allocation.
Collaboration & Synergies
- Ensure smooth collaboration with all Sun Pharma sites and functions to leverage synergies and improve quality management.
- Follow EHS policies and maintain compliance with GMP requirements.

Minimum Education & Experience Requirements

Education: Science and Pharmacy Graduates or Equivalent.
Experience: 20+ years in pharmaceutical quality management leadership roles, with experience in a similar role currently.

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Site Quality Head

Job Description

Position Summary

Key Responsibilities

Minimum Education & Experience Requirements

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