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QA Head – Pharma Sterile Formulations

https://www.randstad.com Logo

Randstad

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Location:
India , Hyderabad

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

QA head – Pharma Sterile Formulations. Location: Jeedimetla Unit 2.

Job Responsibility:

  • Perform online monitoring and in-process checks during manufacturing, filling, and packing operations in aseptic areas to ensure adherence to the Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOPs)
  • Conduct thorough review and approval of BMRs, Batch Packaging Records (BPRs), quality control data, and other cGMP documents for completeness, accuracy, and data integrity prior to final product release
  • Initiate, investigate, and review deviations, non-conformities, Out-of-Specification (OOS), and Out-of-Trend (OOT) incidents. Ensure timely identification of root causes and the implementation of effective Corrective and Preventive Actions (CAPA)
  • Oversee and verify the routine environmental monitoring program for viable and non-viable particles in classified areas (e.g., Grade A, B, C, D), including air and surface sampling. Review and trend EM data and investigate any excursions
  • Monitor and ensure personnel maintain strict aseptic techniques and proper gowning procedures within the cleanroom environments. Participate in and execute aseptic process simulations (media fills)
  • Review and approve validation protocols and reports for equipment, facilities, utilities, cleaning procedures, and sterilization cycles (e.g., moist heat, dry heat, filtration)
  • Coordinate and participate in internal quality audits and support external regulatory inspections (e.g., FDA, MHRA, WHO) and customer audits. Assist in preparing responses to audit findings and ensuring timely closure of action items
  • Develop and/or deliver training programs to manufacturing and QC personnel on GMP requirements, SOPs, aseptic techniques, and quality systems
  • Participate in the quality assessment and qualification of raw material and primary packaging suppliers and contract manufacturers/laboratories
  • Manage the change control system, performing risk assessments and impact assessments for proposed changes to processes, materials, or equipment, ensuring no negative impact on product quality or regulatory compliance

Requirements:

  • B. Pharm, M.Pharm or M. Sc related in pharmaceutical science
  • 10-15 years in Pharmaceutical QA with a strong preference for experience in sterile formulations
  • Core experience in manufacturing of eye drops, ear drops and nasal sprays

Additional Information:

Job Posted:
February 14, 2026

Expiration:
March 28, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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