Executive - Operation

5 months ago

India DHL Full time

Handling documentation related to QA activities such as global SOPs, specifications, Process Data Sheet, etc. - Preparation, Monitoring and Implementation of SOPs & formats as would be applicable for TP site. - Handling of complaints, Deviations, Change control, CAPA. - Insure timely closure of CAPAs, Change control and Deviations.
- Facilitating External / Customer / Regulatory Audits. - Conduct training programs for site personnel with respect to SOPs and applicable guidelines. - Review and up gradation of site documents/ SOPs as per the regulatory / customer requirements. - Ensuring approved vendor status.
- To perform vendor evaluation. - Monitor and review Equipment qualifications and area qualification (temperature mapping). - Ensure timely calibration of temperature monitoring instruments. Maintaining and updating yearly calibration schedule.
- Ensuring trained status of personnel involved in applicable product related activities - Day to day monitoring of activities applicable to process quality. - To perform site audits with respect to GxP. - Assist in the development and maintenance of the quality systems with clients and DSC Healthcare operations to ensure that all activities in the warehouse are carried out according to approved SOPs and regulatory guidelines (GMP, GDP etc) - Maintain and monitor QA site and client related activities through providing timely training on GMP and quality related processes, support operational training needs as specified by the site manager - Support operations and QA Management in the preparation and review of relevant procedures, work instructions or quality documentation. - Support the follow-up and closure of audit issues in a timely manner - Support client audits and provision of requested information - Ensure DSC meets the requirements in compliance with client standards and Quality Agreements and Indian Regulatory.
- Ensure site functions such as Pest control, preventative maintenance, cleaning are being effectively managed by Site management - escalation of issues where necessary - Support calibration and validation schedule. 2 to 3 years in pharmaceutical / Medical device warehousing industry preferably from Quality Assurance Should be M. Pharm / B. Pharm graduate.

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