Umesh I. Asole

· Over all GMP function.

· Handling and maintaining the quality management system such as change control, deviation, OOS etc.

· Conducting GMP training programme.

· Reviewing completed BMR and laboratory records before release for distribution.

· Review of SOPs, Formats and quality documents.

· Reviewing and approval of the validation protocols and reports.

· Reviewing and approval of the APQR.

· Reviewing the internal audit schedules and checklists and to conduct audit accordingly.

Review of qualification protocols and reports for instruments and equipment’s.

· Making sure that the materials are appropriately tested and the results are reported.

· Review and approval of stability summary of batches.

· Inspection of production operation periodically and check on the implementation of Standard Operating procedures (SOP) during the Production operation.

· Checking the housekeeping and cleanliness of the work places and cleanliness of the working personnel in all departments.

· Overlooking and maintaining complete QC department.

Training on all fronts effecting plant and product quality to people and tracking and measuring the training.

· Maintenance of job, training record of all personnel.

· Handling of market complaint, return goods, recall etc.

· Reviewing of Annual Product Review (APR).

· Weekly, monthly review of CMO activity and meeting with CMO.

· Customer audit handling and compliance monitoring.

· Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

· Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

• Company Overview: API and speciality chemical plant. Received FDA manufacturing license in 2018, MH FDA GMP Certificate in 2019, WHO GMP certificate in 2020. Now working towards USFDA, EDQM.
• Overall GMP function (APIs and specialty chemicals)
• Handling FDA and Regulatory related Activity
• Handling and maintaining the Quality management systems such as change control, deviation, OOS etc.
• Checking of Technology transfer documents and approval M.
• Approval of Batch record and release of batches for dispatch.
• Conducting GMP training program.
• Handling market complaints and investigation.
• Review and approval validation activities (Process validation, cleaning validation etc.).
• Monitored process validation execution and completion as per acceptance criteria.
• Evaluation and approval of Vendor qualification.
• Preparation, review and approval of departmental Standard Operating Procedures
• Performing Internal Audits.
• API and speciality chemical plant. Received FDA manufacturing license in 2018, MH FDA GMP Certificate in 2019, WHO GMP certificate in 2020. Now working towards USFDA, EDQM.
• Achievements: Start QA department as soon as joined, developed procedures and protocols, Plant approval in 2017, Manufacturing license in 2018, GMP certificate from MH FDA in 2019, WHO GMP certification in 2020.

• Company Overview: API Plant.
• Overall GMP function (APIs and specialty chemicals)
• Handling and maintaining the Quality management systems such as change control, deviation, OOS etc.
• Checking of MPCR and Approval of Master as well as executed BPCR.
• Approval of Batch record and release of batches for dispatch.
• Conducting GMP training program.
• Handling market complaints and investigation.
• Review and approval validation activities (Process validation, cleaning validation etc.).
• Monitored process validation execution and completion as per acceptance criteria.
• Evaluation and approval of Vendor qualification.
• Preparation, review and approval of departmental Standard Operating Procedures
• Performing Internal Audits.
• Evaluating deviations, fault report & complaints and with proper CAPA.
• Selection and approval of the contract manufacturing and testing facilities.
• Co-ordination with RA for annual updation, DMF filling or Regulatory requirements.
• Review and approval of annual product review.
• API Plant.
• Certified for Internal auditor ISO 9001-2008.

• Overall GMP function (APIs and contract manufacturing)
• Technology transfer document preparation, review and approval.
• Process hazard analysis review and co-ordination in HAZOP study.
• Handling and maintaining the Quality management systems such as change control, deviation, complaints, Calibration program, OOS etc.
• Selection and approval of the contract manufacturing and testing facilities.
• Preparation, review and approval of departmental Standard Operating Procedures
• Performing Internal Audits.
• Imparting training to the concerned as and when required based on updating/changes.
• Approval of Batch record and release of batches for dispatch.
• Evaluating deviations, fault report & complaints.
• Ensuring that goods are produced according to protocols accepted for registration.

• Preparation of standard procedures according to quality systems.
• Examine returned goods, to determined whether they should be released or reprocessed or destroyed.
• Be notified of all circumstances which may affect the quality and quantity of the products.
• Review the records relating to each product.
• To conduct the self inspection and/or quality audit.
• Co-ordination with RA for annual updation, DMF filling or Regulatory requirements.
• Preparation of Annual Product Quality Review report and validation protocol/ reports.

• Preparation of GMP documentation and review.
• Handling of change control, deviation, OOS, etc.
• Preparation of validation protocols and Compilation of reports.

• Handling of multi-effect evaporator and agitated thin film dryer.