QA Head

Location: Jeedimetla Unit 2

Education : B. Pharm or M. Sc related in pharmaceutical science

Experience: 10-15 years in Pharmaceutical QA with a strong preference for experience in sterile formulations.

Key Responsibilities

• Core experience in manufacturing of eye drops ear drops and nasal sprays.
• 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.