Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India.
Job Title (India Specific): Manager – Quality
Reports To: Director – RA, Quality & Technical
Business Unit: Business Quality, Janssen India
Role Type (IC / Supervisor): Individual Contributor
Job Location: Mumbai
Position Summary: The person would be required to establish, implement and maintain a quality framework that supports key GMP and GDP processes within and across the Local Operating Company. Support local operating company management boards in meeting business and compliance requirements through proactive quality management.
Job Responsibilities
Regulatory Compliance:
- To ensure that the Janssen India products, packaging components, labeling meet the local regulatory requirements
- To ensure that all changes related to J&J products and critical systems at external manufacturing sites and within Janssen India are managed through change control system. The changes are assessed for its impact, executed & closed in compliance the regulatory & corporate requirements.
Deviation /Non-Conformance Management:
- To ensure that all deviations and non-conformances at external manufacturing sites related to J&J products and critical systems are suitably, scientifically and logically handled, documented, investigated for root cause, assessed for its impact on product quality and safety; and appropriate Corrective actions are taken to mitigate the effect of deviation or non-conformance on the Product.
Quality, Compliance and SAP transaction of JSC site products imported & sold in India:
- To ensure that the JSC Site products imported in India are released in ERP (SAP System) after satisfactory evaluation of the temperature data (for cold chain products), certificate of analysis, certificate of compliance and health authority test reports (wherever applicable).
- To escalate the issues pertaining to the product, temperature excursion to the JSC Site Quality in event of any product quality or shipment issue via PQMS.
Complaint handling, PQMS and EDGE2 Management:
- To receive, acknowledge, log, investigate, assess the incoming complaints timely. To assess the criticality and impact of the complaint from a quality perspective and timely forward the complaints to the EM and adverse events to the LSO for reconciliation, investigation and closure.
- To update the complaint handling procedure as per current J&J standard and to train the all concerned employees.
Qualifications: At least 10 years’ of relevant experience in Pharma industry. Master of Pharmacy with specialization in Quality Assurance.
