Sheetal Sheth Email & Phone Number

Mumbai, Mh, In

Ahmedabad, Gujarat, India

Lead the plant efforts in implementing QMS Interface with subsidiary, divisional and global quality teams for guidance/support & drive implementation programs.Liaising with the Government bodies - FDA and Legal Metrology for new product approvals, layout changes, technical person appointment, license renewals, weighing systems stamping activity inspection at factory. Maintaining all relevant records and documentation for legal compliance and inspection during audits.Liaising with external consultants for legalisation and appostilization of documents for exports. Roll out quality internal audit programs and ensure timely closure of internal audit observations.Responsible for managing all QMS documents & implementation of change control quality requirements. Implementing development and training schemes for employees towards sustenance of QM guidelines and ensure compliance to GMP, GDP and ISO22716. execution of corrective and preventive actions for quality issues. Participate to integrate between Quality, EOHS, BMOS and MANEX.Undertake Supplier audits & qualification. Support FFPR Process along with Core team by participating in trials leading to improvement of existing product and development of new products. Maintaining of records, FDA documents and aligning inventions with Right First Time and trials at factory. Partner with external teams during GMP (ISO 22716) and RSPO audits. Responsible for carrying out thorough investigation & establish CAPA for any consumer and customer complaints received.Support in Overall lab functions including instrument AMC, Calibration, Preventive Maintenance And procurement of Consumables for Analytical & Microbiology labs.Coordinating the work assignments within the Quality department and delivering Quality improvement projects on-time.Support in timely release of batches from SAP.Preparing & Providing Quality related documents like TDS, CoAs, MSDS for Export and CSD needs.Participating in Microbiology Risk Assessment (MRA)

Section head/ team leader for Antimicrobial Susceptibility Testing, Ready Prepared Media, Freeze Dried and Differential Discs Sections. Actively involved in R & D work of these sections namely carrying up gradation of existing products, stability studies and testing of trial batches. Also responsible for preparing literature related to the above mentioned products. Other responsibilities includes carrying out sterility testing of various products, raw material analysis, calibration of instruments, Documentation as per ISO and WHO-GMP norms, Training new joiners, Complaint and query handling, site visits at customer end, Training marketing team regarding the new products and existing products. Maintaining records in SAP system. Facing internal and external audits. Auditing other departmental activities as a lead auditor for internal audit for ISO 9001, ISO 13485 and WHO GMP. Involved in preparing documents and collecting data for CE marking. Preparing SOPs for various testing and calibration techniques as per the QAP guidelines

Worked for various projects like testing the efficacy of soaps, testing the efficacy of various disinfectants, checking the presence of pathogens in various products, antibiotic sensitivity, protein analysis by PAGE, checking the efficiency of various water filters by performing bacterial and plaque assays, MIC testing of herbal products, Identification of fungus from infected products

Responsible for conducting MIC for various products and setting up its standards, checking the sterility of the containers of drugs, syrups and various products. Collecting samples from various machines, environmental analysis, checking the quality of packaging materials

Masters Of Science, Microbiology, First

Relevant coursework: General Microbiology, Microbial Biochemistry, Microbial ecology, Applied Microbiology, Microbial Genetics, Immunology.

Bachelor Of Science, Microbiology; Biotechnology, First

Relevant coursework: Genetics, Virology, Immunology and Medical Microbiology, Biochemistry, Industrial Microbiology, Biotechnology, Plant.