Our product strictly complying with all statutory regulations and implementing the international norm and practice. We are committed to consistently deliver enhanced value to our customers, through continual improvement of our process and System by way of innovation technology and Knowledge management. To provide services that totally satisfies our customer needs of quality, Safety, efficacy and Timely delivery of the product.,

Responsibilities of the Quality Assurance:

• Ensure compliance to National and International regulatory cGMP requirements
• Approve and verify implementation of defined systems, standards and procedures
• Ensure availability of approved procedures and specifications for reference
• Review Batch Manufacturing and testing Records, before giving product release
• Review and Authorize Validation Master Plan, Protocols and provide support for validations
• Ensure compliance of Change control procedures
• Ensure Induction and training of employees as per Corporate "Induction and Training" Policy
• Ensure compliance of cGMP's through audits
• Carry out Process controls, including in-process checks/inspections/line clearances.
• Inspection of final packed stock, before release
• Investigate complaints, deviations, quality incidents and non-conformances
• Handling of regulatory inspections at the site
• Take actions on Product recalls and investigate the reasons
• Ensure implementation of amendments in specifications and procedures as per current pharmacopoeial standards
• Ensure implementation of Pest and rodent controls, as per defined schedules
• Review Product stability reports
• Review Batch Manufacturing, Batch Packing Records, verify reconciliation of batch inputs, batch yields and finally release the product
• Document control
• Ensure cGMP / GLP training to the staff
• Ensure proper archival and fast retrieval of records
• Evaluation of external analytical laboratories and all those providing the contract services