Head – Quality Assurance (QA)

Job Title: Head – Quality Assurance (QA)

Department: Quality

Location: Amravati Maharashtra
Reports To: Director
Team Size: 10

Job Purpose:

To lead and manage the entire Quality Assurance function of the organization, ensuring compliance with regulatory requirements, adherence to quality standards, and continuous improvement in processes, products, and systems.

Key Responsibilities:

• Quality Strategy & Leadership
• Define and implement the QA strategy in alignment with company objectives.
• Lead the QA team across plants, departments, and products to ensure consistent quality performance.
• Create a culture of quality ownership throughout the organization.
• System & Compliance Management
• Ensure compliance with ISO, GMP , or other relevant regulatory standards.
• Manage internal and external audits, certifications, and regulatory inspections.
• Develop and maintain SOPs, quality manuals, and documentation systems.
• Product Quality Control
• Establish and monitor quality checkpoints at raw material, in-process, and finished goods stages.
• Drive root cause analysis and CAPA (Corrective and Preventive Actions) for quality deviations.
• Oversee customer complaint analysis and resolution.
• Process Improvement & Risk Management
• Identify and drive continuous improvement initiatives using tools like Six Sigma, Kaizen, etc.
• Conduct risk assessments and implement preventive systems.
• Ensure product traceability and batch validation systems are robust.
• Team Development & Training
• Hire, train, and mentor the QA team.
• Conduct regular training on quality systems, hygiene, audits, and safety.
• Evaluate team performance and ensure alignment with organizational goals.
• Cross-functional Coordination
• Work closely with Production, R&D, Supply Chain, and Sales to ensure quality integration across functions.
• Participate in new product development to ensure quality is built from the design stage.

Key Performance Indicators (KPIs):

• % Right First Time (RFT) production
• Customer complaint rate and resolution time
• Internal audit scores / External audit observations
• Non-conformance report (NCR) trends
• Training hours per QA team member
• Cost of poor quality (COPQ)

Qualifications & Experience:

• Bachelor’s/Master’s degree in Science/Pharma or related field
• 10–20 years of QA experience, with at least 5 years in a leadership role
• Strong knowledge of ISO, GMP or industry-specific regulations

Key Skills:

• Strong analytical and problem-solving skills
• Excellent leadership and people management
• Audit handling and documentation expertise
• Proficient in quality tools (FMEA, SPC, 5S, Root Cause Analysis, etc.)
• Communication and interpersonal skills.

Job Type: Full-time

Schedule:

• Day shift

Work Location: In person