Quality Assurance Specialist

4 hours ago

Pithampur, Madhya Pradesh, India beBeeAssurance Full time ₹ 11,69,384 - ₹ 22,15,298
Quality Assurance Specialist

The Quality Assurance Specialist is responsible for ensuring compliance with regulatory requirements, industry standards and company policies. This includes reviewing and approving batch manufacturing records and batch packaging records, as well as preparing and issuing SOPs, logbooks and controlled documents.

Main Responsibilities:

  • Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs)
  • Prepare, issue and control SOPs, logbooks and controlled documents
  • Evaluate all documentation to ensure adherence to Good Documentation Practices (GDP) and ALCOA principles
  • Investigate deviations, CAPAs, OOS, OOT and change controls
  • Maintain QMS documents and ensure timely closure of quality events
  • Support product quality reviews, PQR and APQR
  • Perform line clearance before production and packaging activities
  • Monitor in-process checks for compliance with approved procedures
  • Verify the usage of approved raw materials and packaging materials
  • Participate in internal audits and prepare for regulatory customer inspections (e.g. FDA, WHO)
  • Implement audit findings and maintain cGMP compliance
  • Conduct or coordinate GMP and GDP training for employees
  • Monitor adherence to SOPs, GMP and safety practices across departments
  • Maintain training records for personnel
  • Review and approve Certificates of Analysis (COA) and Certificates of Compliance
  • Ensure only tested and released materials are used in production
  • Support batch disposition in coordination with QA Manager
  • Participate in equipment, utility and facility qualification (IQ, OQ, PQ)
  • Support validation activities, including process validation, cleaning validation and analytical method validation
  • Contribute to quality risk assessments and mitigation activities
  • Suggest improvements in systems and processes to enhance compliance and efficiency
  • Monitor data integrity throughout all QA QC processes

Required Skills and Qualifications:

Key Qualifications:

  • Strong understanding of regulatory requirements and industry standards
  • Excellent communication and interpersonal skills
  • Ability to work independently and collaboratively as part of a team
  • Detail-oriented with strong organizational skills
  • Proven ability to analyze complex data and make informed decisions
  • Familiarity with quality management systems (QMS) and continuous improvement methodologies

Benefits:

We Offer:

  • Health insurance
  • Paid sick time
  • Provident Fund

Work Environment:

Join Our Team:

As a Quality Assurance Specialist, you will have the opportunity to work in a dynamic and collaborative environment that values innovation, teamwork and continuous improvement. If you are passionate about quality and committed to excellence, we encourage you to apply.

Contact Us:

To learn more about this exciting opportunity, please contact us at 91 8349999795.

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