Quality Head

Job Summary:

We are seeking a highly skilled and experienced Quality head to oversee the calibration and validation processes in our pharmaceutical warehouse. The ideal candidate will ensure compliance with Good Storage and Distribution Practices (GSDP) and maintain the highest standards of quality and safety for our products.

Key Responsibilities:

Calibration:

• Accuracy Verification: Ensure all measurement instruments, such as temperature and humidity sensors, provide accurate readings to maintain product integrity.
• Calibration Plan: Develop and implement a comprehensive calibration plan, detailing procedures, frequency, and responsible personnel to ensure consistent performance.
• Standards and References: Utilize traceable standards and reference materials for calibration to ensure reliability and accuracy.

Validation:

• Consistency and Compliance: Ensure the warehouse environment consistently meets specified conditions for pharmaceutical storage, maintaining product quality.
• Temperature and Humidity Mapping: Conduct comprehensive studies to identify hot and cold spots and ensure relative humidity levels remain within acceptable ranges, preventing product degradation.
• Equipment Validation: Validate temperature-controlled equipment to confirm they maintain required conditions, ensuring product safety.
• Validation Master Plan (VMP): Develop and execute a VMP outlining the overall validation strategy, including objectives, scope, responsibilities, and timelines to ensure systematic validation.

Documentation and Compliance:

• Validation Reports: Prepare comprehensive reports summarizing validation activities, results, deviations, and corrective actions to ensure transparency and accountability.
• Change Control: Manage and document changes to the warehouse environment or equipment impacting validation status to maintain compliance.
• Audit Trails: Maintain audit trails for all validation activities to ensure traceability and accountability.

Additional Responsibilities:

• Complaint Handling: Develop and manage processes for handling customer complaints, ensuring timely resolution and compliance with regulatory requirements to maintain customer satisfaction.
• Recall and Mock Recall: Establish and execute procedures for product recalls and mock recalls to ensure readiness and compliance, minimizing risk to public health.
• Warehouse Safety: Implement and maintain safety protocols in compliance with ISO 45001 standards to ensure a safe working environment for all employees.
• Develop and conduct employee training programs.

Qualifications:

• Degree in pharmacy or related field.
• Minimum 7 years of quality assurance experience in the pharmaceutical industry.
• Strong knowledge of GSDP, quality management systems, and regulatory requirements.
• Internal Auditor Certification.
• Proven training skills.
• Analyze the collected data to identify trends, strengths, weaknesses, and areas for improvement.