Chief Technical Compliance Specialist

7 days ago

Hyderabad Secunderabad Telangana, India beBeeInvestigator Full time

Job Description

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  • Manage and investigate technical complaints to identify root causes and implement corrective actions to prevent recurrence.
  • Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify potential issues.
  • Review and approve complaints as a site Investigation approver.
  • Concurrently manage multiple investigations while prioritizing tasks effectively.
  • Periodically analyze trends in technical complaints to drive business improvements.
  • Participate in audits and inspections, including inspection readiness activities to ensure compliance.
  • Escalate data integrity issues promptly.
  • Develop and implement global Data Integrity initiatives.
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Essential Requirements

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  • More than 10 years of experience in the chemical/pharmaceutical industry or over 5 years of experience in pharmaceutical operations, with in-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Proficient in conducting Root Cause Investigations and collaborating with investigation teams to ensure timely completion.
  • Experienced in cGMP manufacturing, Quality, and Compliance regulations.
  • Action-oriented with strong skills in building relationships, problem-solving, planning, conflict management, coaching, and analytical thinking.
  • Capable of completing routine tasks with minimal direction.
  • Fast learning abilities to manage investigations related to small molecules, biologics, CGT products, medical devices, packaging, and distribution topics.
  • Able to communicate roadblocks and challenges promptly.
  • Excellent verbal and written communication skills.
  • Project Management skills are required.
  • Sound knowledge of current international regulatory requirements and best practices, including EU-GMP guidelines.
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