STANDARD JOB DESCRIPTION

DEPARTMENT Quality JD Ref. No.

ROLE TITLE QA - Support (IPQA) REPORTING TO QALead

EFFECTIVE DATE REVIEW DATE

SUMMARY OF ROLE

The position is responsible for the In-process quality control of medical device at shop floor & ensuring all key quality actions; line clearance at each defined stage of manufacturing & packaging, in-process checks at defined frequency, online review of batch record etc. He/She is responsible to draw the samples e.g. process validation sample, bulk & finished goods sample, stability sample, retain sample. Ensure the GMP compliance at shop floor.

RESPONSIBILITIES

Functional

1. Ensuring GMP compliance at shop floor as per ISO 13485.

2. Dispensing of Raw & Packing Material after verifying that all the raw material are according to the Purchase Order raised by the SAP

3. Giving the line clearance in the manufacturing and packing.

4. Responsible to do the in-process checks at a defined frequency.

5. Responsible for drawing samples from bulk & finished products sending to the quality department.

6. Responsible to draw retain sample and stability sample.

7. Responsible making the daily shop floor activity report.

8. Responsible for taking up the non-compliance (deviation) during shop floor activities and update the Quality manager for Corrective and Preventive Action initiation.

9. Reviewing the completed BMR & BPR and submission to QA for further release for sale.

10. Responsible for managing the SAP Activity (in-process result regarding) on the Shop floor.

11. Responsible for AQL check on finished products manufactured in plaster block and release AQL lot in SAP.

12. Raising the deviation for the non-compliance observed during AQL and getting its CAPA and ensure closure before releasing the batch for BSR transfer

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 )

- 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. (Chemistry)/ ISO 13485 certification

ii. Minimum 2-3 years of work experience in the pharmaceuticals

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

iv. Should be able to take additional responsibility in absence of colleagues / subordinates.

v. Should be able to work in shifts.

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