Site Quality Head

Department: Quality

Designation: General Manager / Sr. General Manager

Educational Qualification: B.Pharma/M.Pharma

Experience required: 20 years to 25 years

• Responsible for management of all aspects of Quality functions including Quality Assurance (QA), Quality Control (QC) and Validation (VD) at Site for the dosage forms at Knovea Pharmaceuticals.
• Define operational strategy & road map for Quality Management System and should be involved in all Quality related matters at site.
• Define Quality Assurance, Quality Control and validations department goals, objectives and strategy in line with compliance, product quality management objectives and regulatory requirements. Accountable for quality of products manufactured and released, monitor overall compliance at site.
• Proactively assesses quality issues and ensures compliance with QA, QC and Validation regulatory requirements in manufacturing operations and track quality assurance, quality control and validation department metrics with manufacturing operations at site and drive them.
• Ensure that the system is in place to release or reject raw materials, intermediates, packaging and labelling materials.
• Ensure that the executed batch production and laboratory records of critical process steps should be reviewed before the release of the finished dosage form for market distribution.
• Ensure that critical investigations are investigated and resolved. Managing investigations and impact/risk assessments for deviations concerning good documentation practices and potential data integrity issues. Taking leadership during any Data integrity observation investigation.
• Ensure that all specifications and master production records should be approved by QA.
• Ensure that all procedures impacting the quality of raw material, intermediates (if any), or dosage form should be approved by QA.
• Ensue that internal audits (self-inspections) are performed at site as per the SOP / schedule.
• Ensure system in place to approve intermediate, raw material and dosage form manufacturers by QA (if applicable).
• Ensure all aspects of the change control process that potentially impact raw material or dosage form quality as per the SOP of change control management.
• Ensuring that all validation and qualification efforts such as process validation, cleaning validation, equipment/facility qualification, and computer system validation are performed as regulatory and cGMP requirements.