Manager Quality Assurance

Job description

JOB DESCRIPTION: Co re Job Responsibilities: 1 Commercial Distribution Quality Assurance: Warehouse/ CFA Audit/ Service Provider: Creating and maintaining warehouse/ CFA/ Service Provider audit schedule Conducting Internal audits of CFAs/ Hubs Tracking and closure of audits Quality visits at warehouses / CFA’s as necessary. Managing Suppliers and performing qualification/ performance assessment/ re- qualification activities Tracking and timely closing CAPA on identified action points arising out of: One Affiliate Program Regional Supplier Audit Regulated monitoring activities Exceptions Identification, preparation, review and updating of Distribution Quality SOPs/ Quality Manual/ documents meeting requirements of regulatory and Abbott (Corporate & Divisional documents) Ensuring over labeling controls at approved Over-labelling facilities in line with Abbott standards Reviewing temperature data of data loggers of imported cold chain products and further sharing approvals to import department Reviewing and approving temperature excursions of products observed during storage & distribution of temperature sensitive products and description reports to mitigate product risks Maintaining calendar for temperature mapping of Warehouse & CFA locations, reviewing and approving temperature mapping documents Monitoring OTMS related activities at Warehouse & CFA locations and ensuring compliance as per requirements Trend analysis for Pest control activities and excursions Customer Complaints handling Receiving, logging in, acknowledging, complaint sample follow up & intimating to manufacturing site for received complaint and further supporting the investigation team with relevant information to facilitate effective investigation. Logging information of complaint in SolTRAQ/Trackwise. Connecting with cross functions and Business teams, as necessary to keep the team aware of the complaints management system and selective cases, as necessary. Ensuring complaint sample retrieval and evaluate spread of event at Abbott C& FA as necessary. Ensure timely response and closure of market customer complaints. Log CAPA in system, where investigation outcome demands the same. Ensuring the service level agreements as per the agreed timelines on customer complaints handling To ensure Affiliate SOP is maintained aligned to EQD documents for customer complaints handling & Product actions. To carry out trend analysis of Complaints AQR / Consortium / Regulatory / Customer audits at Plants and Affiliate Ensure compliance to Customer complaints related activities during audits and track for CAPA, if so arises. To support Pharmaco-Vigilance on Global audits related to Quality sections. Complaints from Regulators Tracking with Regulatory & Legal team in case of FDA queries or complaints to confirm the responses are submitted on time by regulatory department. Documentation To perform gap analysis review wrt general compliance for local & global requirements for the SOPs and practices followed at EPD India Affiliate on Customer Complaints handling. Co-ordinating with Pharmacovigilance for the Health hazard Assessments submitted by the investigating teams Filing and maintaining significant event process as per SOP Restricting product / batch quantity in SAP Restricting or Unrestricting stock in SAP due to Quality Reasons The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)