Product Compliance Specialist

1 week ago

Hyderabad Secunderabad Telangana, India beBeeComplaint Full time ₹ 1,04,000 - ₹ 1,30,878

Job Overview

We are seeking a highly skilled and experienced Quality Specialist to join our team. In this role, you will be responsible for handling Product Technical Complaints (PTCs) for medical devices, pharmaceutical products, biologics, and combination products.

  • Collaborate with internal/external stakeholders, including cross-functional teams, manufacturing sites, customer service, medical information, pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management departments for complaint management.
  • Evaluate complaints for severity and risk, ensuring timely processing and closure of the complaints.
  • Enter complaints into the global database, participate in ad-hoc meetings for product-specific complaint issues, and provide timely feedback on complaint investigations.
  • Manage and ensure compliance of all quality processes and documentation with applicable regulations and standards.
  • Proactively identify areas for improvement and support implementation.
  • Ensure documentation of Hub related GxP activities.
  • Abide by any other responsibilities assigned or aligned by manager.
  • Prepare and update data periodically for team meetings.

Key Responsibilities

The successful candidate will have the following key responsibilities:

  • Classify and categorize PTCs based on potential impact on product quality or patient safety.
  • Act as regional hub for assigned countries, following up with complainants for additional information and complaint sample management.
  • Determine if PTC is associated with adverse event or pharmacovigilance special situation, ensuring respective teams are communicated.
  • Ensure completion of required fields in tools, assign complaints to investigation owning site, and complete investigation.
  • Perform final review, update complaint record, and close as per defined timelines.
  • Ensure acknowledgement of complaint and/or response letter to complainant.
  • Maintain compliance with relevant regulatory requirements for complaint management and reporting.

Requirements

The ideal candidate will possess the following qualifications:

  • Minimum 3-7 years of related experience in pharmaceutical industry.
  • Knowledge of cGMPs, Code of Federal Regulations, and complaint database software and reporting tools.
  • Experience working on manufacturing sites is an added advantage.
  • Bachelor's or Master's degree in Life Sciences, Healthcare, Business Administration, Engineering, or Information Technology.
  • Proficient in problem-solving, attention to detail, and organizational skills.
  • Work in a team-oriented, flexible, and proactive manner.
  • Analytical skills and ability to multitask in a stressful environment.

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