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Quality Operations Specialist

3 weeks ago


Warangal Hyderabad Secunderabad Telangana Nizamabad, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

Job Description:

We are seeking a highly motivated Quality Operations Specialist to join our team. The ideal candidate will have excellent analytical skills, attention to detail, and the ability to work independently in a fast-paced environment.

Responsibilities:

  • Perform Quality Operations services to ensure product quality compliance and regulatory workflows
  • Hold accounts in workflow applications to execute service deliverables
  • Generate and analyze reports in various applications and perform follow-up actions if required
  • Evaluate service-related GxP and non-GxP issues and ensure timely investigation and compliance with operating procedures
  • Ensure compliance with internal quality standards, regulatory requirements, and service level agreements
  • Comply with internal functional operating procedures such as time tracking, KPI reporting, ticket management tools, and other internal systems and processes

ROLE SPECIFIC ACCOUNTABILITIES:

Annual Product Quality Review:

  • Extract data from relevant sources and compile external supplier APQR and/or extracted data into a predefined template
  • Draft conclusion of product quality review and collect contributory reports for product-related evaluations
  • Interact with CMOs and/or manufacturing sites as required
  • Support updating and maintenance of APQR schedule
  • Review APQR report/data for completeness and accuracy
  • Complete APQRs within defined timelines and archive approved APQR documents

Required Skills and Qualifications:

Ideal Background/Requirements:

  • M.Pharm/MBA/Engineering/equivalent degree from a reputable institute
  • Minimum 1 year experience in Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances or products/medical device
  • Basic awareness of GxP compliance requirements

Benefits:

This role offers a dynamic work environment with opportunities for growth and development. The successful candidate will be part of a talented team that is passionate about delivering high-quality results.