Quality Control Head

20+ years

Not Disclosed

India Remote

10 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: Quality Control Head

Job Summary:

The Quality Control Head is accountable for assuring the supply of high-quality, GMP-compliant drug products. This role involves defining the operational strategy for the Quality Control (QC) system at the site, finalizing QC goals and objectives in alignment with Sun Pharma's compliance, product quality management objectives, and regulatory requirements. The QC Head is responsible for managing team performance, driving quality metrics, and ensuring the quality of products manufactured and released in compliance with GMP norms and timelines. The incumbent will also ensure adherence to regulatory requirements, GxP standards, and company policies.

Key Responsibilities:

Compliance and Regulatory Oversight:

Assess and ensure compliance with QC regulatory requirements, tracking and reducing quality metrics.
Ensure adherence to cGMP requirements for the release of incoming materials, drug products, and stability studies.
Validate and transfer analytical methods at the site laboratory in accordance with cGMP requirements and regulatory commitments.
Ensure readiness for regulatory agency inspections and internal audits, implementing corrective actions based on findings.

Team Leadership and Development:

Provide strong leadership to the QC team, ensuring that all Quality Control goals and accountabilities are achieved.
Coach and develop direct and indirect reports, offering ongoing performance feedback, annual reviews, and development opportunities.
Manage performance issues consistently and timely.

Quality Control Operations:

Manage QC activities and resources to ensure smooth operations, including the release of materials and finished products.
Design, implement, and review QC processes, SOPs, policies, and standards to ensure compliance.
Develop and execute continuous improvement initiatives to enhance compliance, drive efficiencies, and cost-effectiveness.
Facilitate harmonization and consistent implementation of quality systems and procedures in alignment with regional and global standards.

Collaboration and Coordination:

Ensure seamless collaboration with all Sun Pharma sites, leveraging synergies to improve quality control processes.
Provide direction and guidance to the team to enhance competence and operational efficiency.

Budgeting and Resource Management:

Develop and manage site QC revenue and capital budgets, including headcount projections.
Track and manage expenditures and headcount to align with the budget over the fiscal year.

Strategic Planning and Reporting:

Design and implement strategies for continuous quality improvement and compliance.
Regularly report on QC performance and quality metrics, ensuring that objectives are met on time and within budget.

Job Requirements:

Educational Qualification:

Required: Science or Pharmacy Graduate or equivalent

Experience:

Minimum Experience: 20+ years in Quality Control, specifically in OSD (Oral Solid Dosage) and Injectables.
Experience with regulatory agencies, especially USFDA, and demonstrated success in managing QC systems for injectables and OSD products.

Skills:

In-depth knowledge of OSD and Injectables manufacturing processes and regulatory requirements.
Expertise in managing quality control operations in a GMP-compliant environment.
Strong leadership skills, with the ability to coach and develop a high-performing team.
Proven experience in regulatory compliance, quality audits, and inspections.
Excellent communication skills and the ability to collaborate across functions and with external stakeholders.

Why Join Us:

Leadership Role: Take charge of Quality Control at a leading pharmaceutical site, ensuring product quality and compliance.
Growth: Drive continuous improvement initiatives and work with cross-functional teams to optimize QC processes.
Impact: Ensure that high-quality, GMP-compliant drug products are delivered on time, meeting all regulatory and quality standards.

If you are an experienced leader in Quality Control, particularly in OSD and Injectables, with a strong regulatory background, apply now to be part of our dynamic team!

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