Specialist, Global Product Quality Complaint Triage and Network
Bristol-Myers Squibb · Hyderabad · onsite · Posted 72d ago
Undisclosed2–6 yrsfulltimeSourced from
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About this role
Job Summary
Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.
Position: Specialist, Global Product Quality Complaint Triage and Network
Location: Hyderabad, India
As the Specialist for Global Product Quality Complaint Triage, you will be responsible for the accurate and timely review, evaluation, and assignment of incoming Product Quality Complaints (PQCs) in a dynamic, high-volume environment. Reporting to the Associate Director of Global Product Quality Complaints, you will work closely with various stakeholders across the organization to ensure compliant and efficient management of PQCs. Your role will involve maintaining a thorough understanding of applicable procedures and PQC intake routes, managing PQC mailboxes, and liaising with investigation sites to deliver high-quality, comprehensive investigation reports. You will apply critical thinking and risk-appropriate timelines to expedite the processing of critical complaints, ensuring timely escalations and accurate assessments. Your responsibilities will also include supporting continuous improvement initiatives, being audit-ready, and providing subject matter expertise during audits and inspections. Additionally, you will engage proactively with both upstream and downstream partners to resolve issues and support the overall quality management system. Your ability to prioritize, manage multiple tasks, and maintain collaborative relationships with stakeholders globally will be essential in driving the success of the PQC processes.
Key Responsibilities - Responsible for accurate timely review, evaluation and assignment of incoming Product Quality Complaints (PQCs) in a fast-paced, high-volume, high-complexity environment within established performance requirements (within one business day, >99% Right First Time).
- Responsible to maintain high level knowledge and understanding of applicable procedures appropriate to processing of Product Quality Complaints for BMS products (Pharmaceutical, Biological, Devices, Combination products).
- Responsible to maintain expert knowledge and understanding of PQC intake routes and maintain collaborative partnerships with stakeholders for intake of PQCs.
- Responsible to manage PQC mailboxes as a source of intake for PQCs.
- Responsible to maintain knowledge of BMS product network, product portfolio, and PQC defect categories with respect to BMS products, commensurate to delivery of timely and right first time processing of Product Quality Complaints from receipt and through to investigation assignment.
- Ensure that critical thinking and risk-appropriate timelines are applied to the triage and processing of PQCs. Expedite category complaints will be managed with due urgency. Responsible to deliver timely escalations to investigation sites, market quality, and senior management as appropriate.
- Responsible to liaise with investigation sites to deliver high quality, on-time, comprehensive investigation reports for BMS Quality approval.
- Responsible to assess reported information for accuracy and completeness, and to facilitate the collection of required data and information to support timely assessments and investigations.
- Apply critical thinking in the receipt review of sample photographs, and in the determination of sample return requirements in support of complaint investigations.
- Assess provided information and secure required additional information as required to support product replacement and/or reimbursement processes where applicable.
- Engage proactively, collaboratively timely with upstream partners (Medical Information, Worldwide Patient Safety Case Intake Processing, Third Party Service providers e.g. Call Centers etc) and with downstream partners (investigation sites, market Quality etc) to resolve triage assignment inaccuracies and issues to deliver timely resolution and support timely investigation processes.
- Use risk time appropriate communication means to engage with and resolve issues with upstream downstream partners (phone, Teams preferred over email).
- Escalate to PQC management unexpected/undesired trends observed during processing of PQC records.
- Apply proactive means to support continuous improvement of the triage network processes for PQC. Engage actively with stakeholders and PQC management to continuously improve applicable performance metrics.
- Perform review and closure of designated PQC record types as prescribed in PQC procedures.
- Be PQC inspection audit-ready at all times.
- Provide Subject Matter Expert (SME) support during audits and inspections for PQC.
- Act as PQC SME for continuous improvement projects.
- Perform activities related to owner role for specified investigation types, e.g. Suspect Product, Product Quality Complaints, Lack of Effect, Serialization etc
- As required by PQC management and Network Quality Leadership:
- Provide inputs and insights to metrics assessments for PQC intake, triage, due diligence activities, sample/photo retrieval, investigation assignments, RFT processing through investigation completion, adherence to timelines etc
- Receive feedback and align collaboratively on improvements and/or process changes to support Right First Time processing of PQC records
- Generate ad-hoc reports from VEEVA Infinity related to Product Quality Complaints
- Complete document reconciliation of PQCs received and transferred between intake and processing partners as prescribed by BMS procedures. Highlight escalate irregularities to PQC management for timely resolution. Maintain evidence of all reconciliations in eQMS are required by applicable procedures.
- Maintain accurate and current data in PQC Sharepoint sites
- Support timely archival of PQC related documents
- Provide support to Network Quality, Distribution Quality, Product Surety, Serialization Operations, Serialization Quality Operations organizations
- Participate in PQC Community of Practice, Local Process Owner Community of Practice
Degree/Certification/Licensure
- Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
- Excellent communication with management, peers, and other functional areas
- In-depth understanding of global regulatory environment with respect to Product Quality Complaint processing
- Excellent understanding of product formulation presentation types, defect categories applicable to each, and the inherent risk that defect types pose to patient safety (Solid Oral Dose, Device/Combination, Topical, Liquid / Suspension / Powder / Freeze-Dried Parenteral etc)
- Ability to apply critical thinking in a high-volume, fast-paced environment, in the knowledge that decisions taken support patient safety
- Ability to prioritize while balancing multiple tasks
- Demonstrated experience in risk-informed decision making while working with complex processes
- Highly organized, detail oriented, efficient operator in a fast-paced environment
- Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders
- Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments
Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.
Sourced from naukri
Skills
Due Diligenceclinical trialsProduct qualitydata privacyloscardiovascularpatient safetyDownstreamauditsHematologyImmunologyPharmacyoncologyManufacturingoperationsPharmaceuticalLife Sciencesquality management
About Bristol-Myers Squibb
Bristol-Myers Squibb
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We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.
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