How to know about QA Role and Responsibilities in Pharma

* Here we are discussing about Role and Responsibilities of QA officers in Pharma industry.

* Ensure SOP's are available for all the quality related activities and they are current.

* Approving procedures like sop's specifications, the method of analysis, bpcr's, master formula and forms.

* Ensure internal audits are carried out as per schedule and necessary corrective actions are taken.

* Ensure changes are handled properly and co-ordinate with regulatory affairs dept for speed approvals.

* Preparations of master validation plans and review and approval of validation protocols and reports.

* Handling of customer complaince.

* Ensure maintenance and calibration and validation of equipment/instrument is carried out as per schedule.

* Preparation of annual product quality review reports.

* Ensure proper archiving and retrieval of documents.

* Ensure external audits complaints.

* Ensure vendor qualifications.

* Ensure that training needs of all departments.

* Prepare the site for the customer or regulatory audits.

* Ensure prompt responce and complainces.

* Monitoring of quality related activities in all departments.

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