Vidya Sagar Dasari Email & Phone Number

2550 Argentia Road, Suite 119 Mississauga, On L5N 5R1

Hyderabad Area, India

Maintained all aspects of the corporate quality management, Supervising all regulatory compliance activities and helping to enforce quality assurance policies and best practice principles covering the safety, production and inspection.• Monitored and audited processes and products to ensure high standards of quality• Provided weekly and monthly reports to senior managers on key performance indicators• Identified training needs and recommendations to ensure predictable execution and continuous improvement • Kept quality documentation up to date and ensured that all QA records, data & information are available to managers • Reviewed and updated quality plans, quality manual, SOP's and work instructions • Performed troubleshooting, RCA, CAPA involving 4M and 8D methodologies • Prepared and analysed process data / information for the purpose of management review• Ensured that processes needed for QMS are effectively implemented and maintained across all manufacturing locations• Liaise with the external assessment bodies on all matters related to the external accreditation processes

Hyderabad Area, India

Ensured that manufacturing, packing, labelling, testing, distribution and release of Active Pharmaceutical Ingredients (API's) is done in way that takes into account the GMP requirements. Monitored and reviewed that established quality management system is effectively implemented and maintained and enforce company's Quality and Safety Policies.• Improved the quick scale up of new drug products (for cost and quality) through process engineering lab by sharing value added feedback to R&D and Production• Efficiently maintained all quality documentation and records as per the GMP requirements• Successfully led quality team during regulatory and customer audits• Monitored and reviewed systems and processes with a view to support continuous improvement• Provided assistance in reviewing and approval of change controls• Created and implemented systems for trending production and performance quality levels• Worked closely with QC and Production team to resolve open issues resulting from internal audits, and record review

Hyderabad Area, India

Maintained Quality documents and records up to date. Review and approval of batch productions records and product test reports. Performed process validations, equipment and facility qualifications. Review and approval of instrument and equipment calibration reports. Successfully Led quality team during regulatory and customer audits and prepared audit compliance reports.Coordinated with relevant functional groups to review changes pertaining to processes and equipment and ensure closure of change control reports. Performed internal audits as per the yearly audit plan and schedules. Monitored the closure of non conformance reports and follow up.Coordinated in management review meetings and prepared minutes and provided information to managers based on weekly and monthly quality reports.Prepared annual product quality review (APQR) reports and trends

Hyderabad Area, India

Prepared SOP's, equipment operating procedures, in-process check lists, formats, quality manual, site master file, Onsite Emergency Plan, Validation protocols, Review and approval of completed batch production records. Assisting in customer and third party audits. Performed internal audits as per the annual audit plan, preparation of audit reports, closure of non conformance and submission of quarterly audit reports to management. Coordinate and conduct management review meetings and circulate the minutes of MRM to all functional heads.