Job Description

Role & responsibilities Quality checks Ensure raw material, packing material, consumables material checking Ensure Work In Progress (WIP) check In process quality check and correction feedback Quality process adherence audit Ensure Final quality monitoring Preparing samples as per customer requirement Preparation of COA/ other documents required for samples Implementing CAPA recommendations and recommend trainings required Ensuring consistent quality by establishing GMP systems, validating processes, and providing documentation Adhere to FDA and GMP regulations Production Production planning and scheduling adherence Batch manufacturing card allocation Ensure the pilot batches match the standards Production targets Ensuring execution and inspection/ testing of incoming and outgoing products conforming to quality conformance Job allocation to the team as per requirement Audit of QC processes Quality audit process to assess quality plan adherence & staff competence Coordinate with customers or external auditors Coordinate with departments for implementation of audit requirements QMS audit as per certifications Non-compliance investigation and closure Quality Formulation development Development of new analytical test/ parameters Ensuring products as per customer expectations and specifications Quality Resource Planning Instruments, manpower and facilities that might be required or to be upgraded Training Conducting trainings on process improvements Compliance Audit certification compliance Documentation & reports Preparation of manuals for specifications and methods of analysis including process control samples for all products and packaging materials, and periodic updating as needed Maintaining records of all quality audits undertaken Monitoring records of all quality test undertaken Monitoring the documents of QC for traceability and completeness as per customer norms and certification guidelines Prepare Management reports Prepare documents as per country norms Maintaining the production records Customer Complaints Root cause analysis of customer complaints Making reports and resolution Preparation and review of CAPA Preferred candidate profile Perks and benefits