Senior Officer - Quality Assurance

Job Title

Business Unit

Job Grade

Location :

“Create your own sunshine”

Are You Ready to Create Your Own Sunshine?

Key Responsibilities

• Batch Release: To perform usage decision of finished product, Intermediate and recovered solvent batches and ensure all requirements as per SOPs, Specifications, Customer & Regulatory Commitments, Exhibit / PPQ Batch Protocol (as applicable) are complied prior to taking Usage Decision on a batch.
• To perform sampling and sample distribution of Finished Product & Intermediates as per SOP.
• Control and review of Batch production records of APIs, intermediate & recovered solvents of all API plants.
• To review of batch production records and analytical records before release of batches for distribution and to release delivery order.
• Preparation and review of Annual Product Review as per SOP.
• Management of Retention samples including annual inspection of API and to maintain related records.
• To perform following activities in Track wise (CQMS) system as per requirement.
• Sampling investigation
• QA review and verification tasks
• Initiation of change controls and investigation/deviation.
• To perform environmental monitoring of general API plants, preparation and review of trend and its evaluation as per SOP.
• To provide market and regulatory samples as per requirement.
• Generation, logging, monitoring and closure of TRF as per SOP.
• Trending of analytical data for APIs as per SOP.
• To provide accurate and adequate data to Marketing Regulatory Affairs department for filing to various regulatory agencies.
• Preparation and maintenance of finished product label in system for APIs and perform reconciliation of API FG labels.
• Work allotment and planning.
• To perform transport validation activity as per SOP.
• Handling of market returned materials as per SOP.
  

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Job Requirements

Educational Qualification

Experience

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