QA Specialist

4 days ago

Hyderabad, Telangana, India beBeeQuality Full time ₹ 2,40,000 - ₹ 3,60,000
Job Opportunity:

We are seeking a qualified QA Executive to support daily quality assurance activities in our pharmaceutical facility. The role will focus on documentation review, QA activities, and ensuring compliance with regulatory standards.

Responsibilities:
  • Review batch manufacturing and packing records for accuracy and completeness
  • Ensure line clearance for production and packaging activities is completed according to procedures
  • Support the handling of deviations, change controls, CAPA, and incident reports in a timely manner
  • Maintain compliance with cGMP and Revised Schedule M requirements throughout the production process
  • Participate in in-process checks and quality monitoring to ensure product quality
  • Assist in the preparation and review of SOPs, logbooks, and other controlled documents
  • Support internal audits and regulatory inspection readiness by maintaining accurate records and documentation
Qualifications and Skills:
  • Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field
  • Minimum 2-4 years of experience in QA in a pharmaceutical company
  • Strong understanding of cGMP and QMS principles, with the ability to apply them in a fast-paced environment
  • Excellent documentation and communication skills, with the ability to effectively interact with cross-functional teams
Key Responsibilities (Mid-Level):
  • Review and approval of batch records, logbooks, and controlled documents for accuracy and completeness
  • Oversee line clearance, in-process checks, and QA compliance to ensure product quality
  • Lead and investigate deviations, OOS, OOT, change controls, and CAPA in a timely and effective manner
  • Coordinate with production, QC, and engineering teams to ensure quality compliance
  • Manage document control, issuance, archival, and retrieval systems to maintain accurate records
  • Support vendor qualification and raw material quality compliance to ensure product safety
  • Prepare for and participate in internal audits and regulatory inspections to demonstrate compliance
  • Mentor and guide junior QA team members to ensure knowledge sharing and skill development
Qualifications (Mid-Level):
  • Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field
  • Minimum 4-8 years of QA experience in a pharmaceutical manufacturing unit
  • Strong knowledge of QMS, regulatory compliance, and cGMP, with the ability to apply them in a complex environment
  • Experience in facing audits from USFDA, WHO, and other regulatory bodies, with a strong track record of compliance
  • Excellent analytical, communication, and leadership skills, with the ability to motivate and guide teams

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