Quailty Assurance Executive

**Experience**: 3/4 yrs.(Experience in a Pharmaceutical industry)

**Job location**: Wada, Maharashtra.

**Qualifications**: Minimum B.sc and B.Pharma.

**FDA Approval Compulsory**

**JOB DESCRIPTION**:

- Quality system planning, implementation of cGMP in plant
- In-process quality assurance activity
- To maintains compliance of manufacturing activity with regulatory requirements.
- Preparation and approval of validation master plan and maintaining valid process and planning validation strategy.
- To approve the master production records like master formula records, batch manufacturing records, batch packaging records, SOP, Formats, Protocol & Reports, etc.,
- To reviewing production records to ensure that no errors have occurred, and if errors have occurred, that they have been fully investigated
- To routinely monitor all buildings and facilities to ensure that they are clean and maintained in an orderly state of repairs.
- To review any pertinent documentation, i.e. logs and records, to verify that procedures for sanitation and maintenance are being performed properly.
- To issuance and control of batch manufacturing records and batch packaging records, SOP, Formats and control of documentation system. Stereo issuance and control
- To approve the artwork at plant level
- To assigning the batch number to product
- Preparation and approval of annual product quality review, trend analysis
- To control on non-conforming materials.
- Batch release for dispatch.
- Handling of self-inspection/internal audit system
- Maintaining QMS section CAPA/ Change Control/ Deviation/Incidence/market complaints/ OOS/OOT etc
- To approve and archive all protocols and reports
- To approve or reject any procedure or specification affecting the purity, quality, strength, or identity of the drug product
- Handling of return and recall
- Handling the failure investigations
- Handlingof hold time study of the product manufactured
- Quality system planning, implementation good laboratory practices in Quality Control lab
- Handling audit compliance
- Handling and execution of the training
- Handling of stability study