Senior QA Manager @ Simpex Pharma -R

Senior QA Manager
Simpex Pharma Private Limited. - Uttarakhand

Organization of Quality Assurance and Quality Control functions. Guidance and support to Regulatory affairs team. Guidance and technical support to loan licence locations. Daily verification of engineering departments Purified water generation system records, Air handling units records, differential pressure/temperature/% RH monitoring records.

Line clearance in manufacturing, packing and sampling area. Responsible for quality assurance of routine products. Follow up of stability studies being carried out at Kotdwar Compliance with GMP requirements. To organize qualifications validations of processes, systems, equipments, utilities with the support of production, stores, quality control and engineering.

Follow up of calibrations/validations required from external parties. Investigating market complaints with implementing remedial measures to avoid recurrence. To control non-conforming products with proper corrective and preventive action. To organize up-gradation of SOPs, STPs and other related documents.

Training the staff for cGMP and safety. To recommend product recall in case of any quality problem. Product Quality Review.
 CLICK HERE TO APPLY