QA/QC Head job vacancy at Bangalore in Aionios Pharma

Job Summary:
The Quality Control (QC) Head at a pharmaceutical head office is responsible for overseeing the overall quality control operations across the company. This role ensures all products meet regulatory standards by managing testing procedures, reviewing data, investigating deviations, and collaborating with manufacturing sites to maintain compliance. The QC Head adheres to cGMP guidelines and reports directly to senior management.
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Key Responsibilities:
Quality System Management:
• Develop, implement, and maintain comprehensive quality systems and procedures to ensure compliance with regulatory requirements (e.g., FDA, ICH).
• Oversee the implementation of standard operating procedures (SOPs) across all QC laboratories.
• Conduct internal audits to assess compliance with quality standards.
Analytical Method Validation and Transfer:
• Lead the validation and transfer of analytical methods for raw materials, in-process materials, and finished products.
• Ensure accurate and reliable analytical methods are used for testing.
Product Testing and Release:
• Review and approve test results for raw materials, in-process materials, and finished products before release.
• Investigate and resolve out-of-specification (OOS) results.
• Monitor stability studies and review stability data to ensure product quality over time.
Deviation Management:
• Lead the investigation of manufacturing deviations, including root cause analysis and corrective action plans (CAPA).
• Ensure timely and effective resolution of quality issues.
Regulatory Compliance:
• Prepare for and support regulatory agency inspections (e.g., FDA, MHRA).
• Stay updated on regulatory changes and ensure compliance with new regulations.
Cross-functional Collaboration:
• Collaborate with manufacturing, quality assurance (QA), and R&D teams to identify and address quality issues.
• Provide technical support for process improvement initiatives.
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Required Skills and Qualifications:
• Advanced degree in Pharmacy, Chemistry, or a related scientific field.
• Extensive experience in pharmaceutical quality control, preferably in a leadership role.
• Thorough understanding of cGMP regulations and guidelines.
• Quite knowledge in analytical techniques like HPLC, GC, UV-Vis, etc.
• Strong problem-solving and analytical skills.
• Excellent communication and leadership abilities.