â–ªPlaying an important role in handling of all regulatory audits like USFDA,EUGMP,TGA,INVIMA,ANVISA,TFDA(Taiwan),TFDA(Tanzania),GCC.
â–ªMarket complaint response review and investigations,
â–ª Review of Batch records and releases of batches as per cGMP compliance,
â–ª Handling of deviation, change controls and CAPA,
â–ª Handling of out of specification results and out of trend results,
â–ª Ensure compliances of Quality systems during batch manufacturing, packing and other activities,
â–ª Master document review.
â–ª Coordination with internal and external customers for Quality related issues: technical agreements and batch related query and responses,
â–ª Coordination with all other dep...