Senior Executive-QA

Preparation, execution and review of protocols for Equipment qualification, Area and HVAC qualification, Utility Qualification including temperature mapping for Non-Sterile and Sterile area as per VMP. Preparation of BMR /BPR as and when required. Preparation and Execution of CMP and CML for Validation Instruments. To coordinate with cross functional team and customer for timely completion of validation activities. To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities. Handling of Media fill related activity Handling of Audits, Internal as well as external. To provide compliances against audit findings and to ensure appropriate corrective actions based on audit findings. Handling of Track Wise related activities and ENSUR related activities (Initiation of documents). Handling of QMS Activities (Incident, Deviation, Investigation etc. ). Maintaining documents as per as per site procedures, Archival and disposition of documents. Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site. To ensure the EHS (Environment, health and safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as per EHS requirement. To attend training session (onsite/ offsite) and provide training to concerned personnel s. Handling/ execution of other job as per the instructions of the superiors.

Bachelor of Pharmacy/Master of Pharmacy or Master in Science, Technical background is preferred.