JOB DESCRIPTION

SUMMARY OF ROLE

The position is responsible for the release of medical device finished products as per ISO 13485 requirement along with review of complete batch record, preparation of product quality review (PQR) of medical device product. Responsible for the management of documents and ensuring the right first time delivery.

RESPONSIBILITIES :

Functional :

- Review of master BMR/BPR, maintain the master record and ensure the document control; issuance, retrieval and maintain the list.

- Responsible to review completed batch records and the analytical reports of the finished goods.

- Ensuring CAPA from the concerned department before finalising the batch record for final release.

- Responsible to release the batch of medical device in SAP system by using quality module and ensuring the quality standard of product as per ISO 13485 requirement.

- Preparation and review of Goods for Sale certificate for new products.

- Responsible for SOPs review of medical device.

- Responsible to prepare Product Quality Review document for medical device's product.

- Maintaining the RFT tracker and provide training to person to improve right first time.

- Initiating Change controls, deviation in trackwise system.

- Responsible to train the person on the Standard operating procedure and cGMP.

- Responsible to carryout the impact assessment assigned by the change control initiator

- Ensuring compliance to minimum standards equal to 100 %

- Responsible for the preparation and review of the Quality Assurance SOP

- Performing any assignment allocated by & under guidance of Quality manager.

- Responsible to do activities as designee in absence of any colleague.

Cross Functional

- Working closely with Production, Warehouse, Engineering, Quality control and Quality Assurance, assisting line managers for the non conformance observed and the corrective action taken on the floor.

Others

- Contribution in audit related activities like documents, system complies etc.Responsibilities towards environment health and safety.

1) To reduce the paper consumption.

2) To reduce the paper wastages.

3) Energy saving.

4) Use of PPE at the work station.

5) Follow the environment health and safety policies.

6) To report the near miss and accidents in the factory.

- Knowledge of Ms Office (Word, Power Point and Excel )

- Good Knowledge of AutoCAD.

- Easily Handle Any Computer Package or Software.

- Should be able to take additional responsibility in absence of any colleague / subordinate

MINIMUM EXPERIENCE/QUALIFICATION

i. B.Pharm/ M.Sc. with ISO 13485 certified

ii. Minimum 3-4 years or above of work experience in the same field.

iii. Basic knowledge of MS office, computer, GMP and SAP.

iv. Should be able to take additional responsibility in absence of the college / subordinate.

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