Quality Compliance Specialist

1 week ago

Srikakulam, Andhra Pradesh, India beBeeQualityAssurance Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

We are seeking a diligent individual to ensure product quality and operational compliance within the regulatory framework. This role involves reviewing real-time investigations, executing in-process activities during shifts, conducting line clearances and material verification.


Responsibilities:
  1. Executing or assigning in-process activities.
  2. Conducting line clearances and material verification.
  3. Overseeing start-up of machines and coordinating sampling activities.
  4. Executing batch records and log books.

Additional Responsibilities:
  1. Reviewing production records.
  2. Creating additional documentation as needed.
  3. Conducting QA documentation with respect to Quality Assurance activities.
  4. Ensuring online documentation and adherence to incident reporting system in case of deviations.
  5. Issuing approved procedures to manufacturing teams.
  6. Verifying basic Good Manufacturing Practice (GMP) requirements.
  7. Following incident management process in case of deviations.
  8. Providing support in complaint investigations by collating data and conducting interviews.
  9. Coordinating cross-functional teams for investigation process, root cause analysis, CAPA documentation and implementation.
  10. Supporting internal and external audit activities following superior instructions.

Qualifications:
  • Minimum 4 years of industrial experience in Quality Assurance/IPQA.
  • B Pharm or Post-Graduation in Life Sciences.

Key Skills:
  • Solid understanding of Quality Systems.
  • In-depth knowledge of pharmaceutical markets including product knowledge, market trends, competitors, and customer needs.
  • Awareness of global cGMP, Current GMP, and regulatory requirements.
  • Strong analytical thinking abilities.
  • Good communication and influencing skills.

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