Specialist, Global Product Quality

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a Quality Complaints Specialist to manage incoming PQCs, review, evaluate, and assign within tight timelines in a fast-paced environment. The role requires knowledge of PQC processes for pharma, biologicals, devices, and combination products, strong English communication, and collaboration with cross-functional teams to ensure timely investigations.

Candidates should have a life sciences degree and familiarity with global regulatory requirements for PQC

Qualifications

• Fluent in English with professional proficiency for reading, writing and speaking
• Excellent communication with management, peers, and other functional areas
• In-depth understanding of global regulatory environment with respect to PQC processing

Responsibilities

• Review, evaluate and assign incoming Product Quality Complaints (PQC) within one business day
• Maintain knowledge of PQC procedures for BMS products including pharmaceutical, biological, devices, and combination products
• Manage PQC intake routes and collaborate with stakeholders for intake of PQCs
• Manage PQC mailboxes as a source of intake
• Maintain knowledge of BMS product network and PQC defect categories
• Apply risk-appropriate timelines to triage and processing of PQCs and escalate as needed
• Liaise with investigation sites to deliver high-quality investigation reports for quality approval

Skills

Fluent English

Excellent communication

Regulatory knowledge

Education

Bachelor of Science (Life Sciences)

Job description

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 frm 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

Qualifications & Experience

• Degree/Certification/Licensure
• Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)
• Required Competencies
• 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