Dr Reddy's Laboratories Limited
Location
Andhra Pradesh | India
Job description
1.1 To ensure and adhere Organization Safety/Quality policies, Procedures and norms effective implementation from time to time.
1.2 Ensure the adherence of SHE standards and policies across the plant with respect to MSI
1.3 Investigation management:
· Ensure to log the incident in SAP/FIORI as per the timelines mentioned in the SOP
· Preparation, review and approval of investigations related to Incident, OOS, OOT, batch failures, Market complaints and recalls.
· Tracking of incident closure and approval of QMS elements within the timelines
· Preparation of trends
1.4 CAPA, change control Quality risk management:
· Log the QMS elements in SAP/FIORI as per the requirement.
· Preparation, review and approval of documents through DOCHUB related to the QMS elements
· Tracking and approval of QMS elements within the timelines
· Preparation of trends for QMS elements
1.5 To review of SOPs, BMR/BPR and all other GMP records as per requirements.
1.6 Audit compliance and Audit management:
· Perform Gap analysis for procedure vs practices
· To participate in GMP/Regulatory Inspections (Internal/External) its compliance.
· Conducting Self inspection and ensure all time audit readiness
1.7 Build organization and people capability by boosting confidence, reduce turnover, increase job security, and stimulate employees to think beyond their role so they can meet future
challenges in a way that adds value to the company and to ensure right first time and Zero Incidents.
1.8 Operational Excellence:
· Preparation and tracking and cost saving policies to reduce of OPEX budget for the plant.
· Improvement plans to improve the quality, safety and efficacy of the product.
· Reducing the complexity and simplifying the activities/ procedures.
1.9 To perform any other task/project assigned by production head from time to time.
B Pharmacy, M Pharmacy, B Tech, BE
Must have following knowldege:
Injectable process, equipment, Aseptic Practices, Sterility Assurance, Qualification & Validation, QMS, Investigation, CAPA, Change control
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