Director Quality Control

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Hyderabad is seeking a qualified professional to manage Product Quality Complaints (PQC) with accuracy and speed. The role focuses on timely triage, assignment, and escalation to ensure Right First Time processing.

Responsibilities include maintaining PQC procedures, coordinating with investigation sites, and delivering high-quality reports for quality approval. Fluency in English and strong communication are essential.

Qualifications

• Must be fluent in English with strong written and verbal communication skills.
• Solid understanding of global regulatory environments related to Product Quality Complaint processing.
• Experience in fast-paced environments with attention to detail and timeliness.

Responsibilities

• Review, evaluate and assign incoming Product Quality Complaints (PQC) within performance targets (within one business day, >99% Right First Time).
• Maintain knowledge of PQC procedures for BMS products (Pharmaceutical, Biological, Devices, Combination products).
• Manage PQC intake routes and collaborate with stakeholders for PQC intake.
• Handle PQC mailboxes as a source of intake for PQCs.
• Understand BMS product network and PQC defect categories to ensure timely processing.

Skills

English proficiency

Communication

Regulatory knowledge

Quality assurance

Education

Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)

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