GM - Quality Control/Quality Assurance - Pharma

Job Description:

Quality Assurance activities at Samba Plant:

- To ensure the compliance of QA/GMP related activities of products manufacture at our manufacturing location.

- To update the documentation as per regulatory guidelines

- To conduct cGMP/cGLP audits for GMP compliance

- To review and update of quality systems and procedures of warehouse, production, engineering, QA to meet the GMP requirements.

- Responsible for investigation of market complaints with the help of inspection records and sending satisfactory replies to the complainants.

- To organize Quality Evaluation programme to improve the quality of product like Post marketing surveillance / techmar study of product, regular inspection of retain sample, review - stability datas shelf life etc.

- Deviation, change control, qualification and validation activities.

To maintain documents:

- To check and upgrade the standard test procedure as per pharmacopoeia change

- To prepare the raw protocol for the raw materials.

- To check and ensure the calibration record as per annual calibration schedule.

- To prepare justification for instruments as per requirements.

- Preparation of IQ, OQ and PQ for the installed instruments .

- To monitor and update the annual maintenance contract of all the instrument.

- Responsible for the investigation for OOS as on required.

- Responsible for the updation of vendor list as per the SOP

Quality Control activities at Samba Plant:

Overall responsible for activities related to raw material , packing material and FG in quality Control

- To ensure proper sampling as per sampling plan by day to day monitoring of receipt of raw material as per production requirement

- Checking of sampling report with entry of raw material in register.

- To ensure the distribution of sample to related section for analysis work

- Every day meeting with production and supply chain people for the requirement as per production plan

- Distribution of work to the chemist and executives as per the production priority .

- To issue the signed protocol along with sample to related chemist.

- To check the chemist working place during analysis and solve problem if required.

- To check raw data of approved material .

- Material is rejected OOS will be followed it .

- To ensure the approved/rejected sticker pasted on every container as per SOP.

- To check and approve certificate of analysis of raw material.

- To visit warehouse daily for an hour to check the activity related to QC.

- Coordination with other department like production, store, purchase and supply chain for smooth running production within a time period.

Daily Training of chemist within department:

- To train and validate the chemist for the analysis work.

- Training of SOP as per the training schedule .

- Arranging the training and troubleshooting session of the instrument from the instrument application engineer for related instrument.

- To train the chemist for GLP aspects in Laboratory