Quality Assurance Specialist

4 days ago

bangalore, India Ad Astra Consultants Full time

Quality Advisor Play a leading role in managing the Healthcare Quality Management System and implementing compliance programs for Transportation and Healthcare facilities to ensure process, procedures and systems are compliant with regional and local regulations and customer requirements. The role Quality Assessment & Standards: Review SOPs and Work Instructions for transportation & fulfillment solutions pertaining to the healthcare industry. Quality Policies: Design, implement & promote policies and procedures for company-wode Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others. Healthcare Quality Management System: Develop, implement & manage the system and develop corresponding training programs. Quality Management: Review documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress. Quality Audit Processes: Design & implement robust internal audit processes to ensure readiness of various functions and processes when audited by regulatory agencies and customer auditors. Certification & Customer Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region. Operations Audit Programs: Lead and conduct External and Vendor audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward and support in issue resolution. Experience Local pharmacist license and may be required to hold licenses on behalf of the company Three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis Working knowledge of current Goods Distribution Practice (cGDP)/Goods Manufacturing Practise cGMP, Good Clinical Practises cGCP, Goods Distribution Practice (GDP & GxP Framework) & ISO13485 for Medical Devices Bachelor’s Degree in Science, Pharmacy or related discipline Soft skills Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards Problem-solving skills to support customer issue resolution Planning & organization skills to ensure proper audit programs are managed effectively Communication skills to facilitate engagements with customer and regulatory agencies Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile and Design Thinking Apply data-driven decision making with the use of data analytics and visualization tools like Power BI

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