Senior Quality Assurance Specialist

5 days ago

Sangli, Maharashtra, India beBeeQuality Full time ₹ 12,00,000 - ₹ 18,00,000

Key qualifications for this position include:

  • 6-8 years of experience in the pharmaceutical industry with a focus on quality assurance.
  • A postgraduate or graduate degree in science or pharmacy from a reputable institution.
  • Hands-on experience and knowledge of quality management systems, including GMP, FDA regulations, and ICH cGMP industry standards.
  • Excellent observational and attention-to-detail skills, as well as strong problem-solving and decision-making capabilities.
About the Role

This role is responsible for ensuring the quality of products during production processes. It involves monitoring and controlling manufacturing processes to comply with regulatory standards and company quality policies.

  • Perform real-time monitoring of production processes to ensure adherence to quality standards.
  • Conduct routine inspections and in-process checks to verify compliance with specifications and protocols.
  • Collaborate with production and quality control teams to address any quality issues promptly.

The ideal candidate will have a strong understanding of GMP, FDA regulations, and ICH cGMP industry standards, as well as excellent documentation and record-keeping skills.

They will also be able to work effectively in a team-oriented, fast-paced environment and have a continuous improvement mindset.

Requirements

Requirements for this role include:

  • A postgraduate or graduate degree in science or pharmacy from a reputable institution.
  • Hands-on experience and knowledge of quality management systems.
  • Strong understanding of GMP, FDA regulations, and ICH cGMP industry standards.
  • Minimum 6-8 years of experience in pharma manufacturing plant preferably API Manufacturing Plant with experience of IPQA in rotational shifts.
  • Proficiency in using quality management software and tools like Trackwise, SAP, etc.
Desired Skills

Desired skills for this role include:

  • Excellent observational and attention-to-detail skills.
  • Ability to work effectively in a team-oriented, fast-paced environment.
  • Strong problem-solving and decision-making capabilities.
  • Good documentation and record-keeping skills.
  • Continuous improvement mindset and ability to handle multiple tasks efficiently.

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