Quality Assurance : To ensure the supply of working standards & related impurities as per customer requirements. Carry out internal audits To organize proper investigation from the section where the deviation has occurred in batch production record. The response of the other departments on deviations occurred and the investigation thereafter. Preparation of Annual product review. Monitoring of customer complaints and International QA for updating customer complaints. Handling of MNCR & CAPA systems. Ensure all QA related proper documentation. Ensuring proper record keeping and timely disposal of QA records including BPR. Preparation of SOPs & work instructions related to Quality Department. Conducting GMP training Interaction with marketing, supply chain, stores, TSS, production, maintenance department for technical support & compliance part as per requirement. Interaction with customers regarding quality issues & providing technical support. Product Quality complaint and monitoring the same for BU Preparing presentation for Operations review and also participate in the same Handling of site related complaints. Investigation and report preparation and sending to TSS/Customer Quality Control: Supervision of Quality Control lab of Raw Materials/instrumentation/bulk drugs and microbiology and ensuring applicable compliances Purchase of QC instruments Instrumentation set up for QC testing Method Validations IQ/OQ/PQ of QC instruments Support Head Site Quality for handling of external audits, coordination with customer, TSS, execution of audit, compliance report to customer Budget preparation of Quality department. Quality Assurance activities in Customer/Regulatory/Internal audits, Supervision of Quality Control lab of Raw Materials/instrumentation/bulk drugs and microbiology IP protection Support documentation centre for general BU Quality related SOP revision and issuance of documents when document officer is on leave. Product Quality in interaction Interactions with Multi- disciplinary teams like TSS, Marketing, supply chain and various departments at site and beyond site also
Candidate should be MTech /MPharma/ MSc / PG in Chemistry with 12+ years of experiance in Pharma industry (API).
Experiance and Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines, ICH guidelines for stability studies, Validation master plan and process validation, Qualification protocols ( URS/DQ/IQ/OQ/PQ).
SAP Knowledge is required.