Sr. No.

Responsibilities

1.0

Preparation and Review of Documents.

1.1

Preparation and Review of Process / Optimization validation protocol and report.

1.2

Preparation and Review of all equipment requalification as per validation schedule

1.3

Preparation and Review of Utility qualification protocol and report as per schedule.

1.4

Preparation and Review of Visual Inspectors qualification & Knapp test protocol and report.

1.5

Preparation and Review of qualification document of equipments. i.e. URS,DQ, FAT, IQ,OQ,PQ

1.6

Preparation and review of Cleaning validation protocol and report.

1.7

Preparation and review of HVAC qualification Protocol and reports.

1.8

Preparation and review of validation master plan.

1.9

Preparation and review of standard operating procedure

1.10

Review of Quality control test report and worksheet for Process validation.

1.11

Preparation and review of temperature mapping protocol and report.

2.0

Execution of the Activity

2.1

Execution of Process validation and process Optimization activity.

2.2

Collect Process validation sample as per protocol.

2.3

Execution of Equipment Requalification activity

2.4

Execution of Utility qualification activity i.e. Nitrogen gas ,Compressed Air ,Pure Steam etc.

2.5

Execution of Visual inspector qualification activity and Knapp test.

2.6

Execution of Equipment initial qualification activity i.e. FAT, IQ, OQ, PQ.

2.7

Execution of cleaning validation activity i.e.



Collect Rinse and swab sample before/after cleaning of various equipment for chemical and microbial analysis.

2.8

Execution of HVAC validation activity.

2.9

Updation of validation master plan annex i.e. Annual qualification schedule, Equipment qualification matrix, life cycle managment,etc.

2.10

Execution of media fill validation activity

2.11

Execution of temperature mapping activity i.e. Area and equipment temperature monitoring.

2.12

Updation of Validation Status Label on instruments and equipments.

3.0

To assign the Identification Number for instruments and equipments.

4.0

To give training of validation protocol and standard operating procedure.

5.0

Handling of QMS related activities.

5.1

To take the change control or deviation as per standard operating procedure.

6.0

To arrange documents as per Guidance document handling, control and distribution procedure and retention of document procedure.

7.0

To issue the document as per Receiving, Control, Issuance, Distribution and Retrieval of Documents procedure.

8.0

To execute the process for temperature controlled product distribution as per procedure of ‘‘Data Logger handling Procedure for Transportation’’

9.0

To proceed for contract party agreement as per procedure of Qualification and Approval of contract services.

10.0

To review drawing and update the master list of drawing as per procedure Management of Layouts, drawings and P & ID diagram.

📌 Officer QA Validation - VN (Gujarat)
🏢 Troikaa Group
📍 Gujarat