Quality Assurance Officer

GNH India

IGNORE IF Already Applied .

Required Qualification:

1. M-Pharm or B-Pharm with Hands-on experience as QA Pharmacist in GMP / GDP environment

2. Good Command over English.

3. Mandatory to have Valid Pharmacy License and PPP.

4. Experience : 5-10 years experience Mandatory*

5. Age Limit : Up to 40 years

1. Preparation, Revision & Training of QA SOP's:

Hands on Experience of SOP Management

Preparation & Revision of QA SOP's in Control Document Management System (CDM'S) as per requirement.

To conduct Training of approved QA Sop's to all concerned persons.

2. Audit & Inspection Readiness:

Preparation of Annual Internal Audits schedule.

Performing Internal Audits as per approved schedule.

Preparation of Internal Audits report.

Raised the CAPA's in Track-wise system after agreement with stakeholders.

Verification of CAPA's effectiveness

after predefined period.

3. Periodic Product Review:

Preparation of Periodic Product Review (PPR) of the products.

4. Preparation of Periodic Product Review (PPR) of the products.

To support contract manufacturing sites for validations during product transfer.

5. Process, Equipment, Facility & Utility Qualification:

To permed change control assessment validation / qualification perspectives.

Preparation and Maintenance of Site Validation Master Plan (SVMP).

Preparation of Monthly presentation on Site validation Steering Committee.

Tracking of monthly re qualification schedule.

ning Validation:

Preparation of Cleaning Validation Protocols & Reports.

Performing Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) Study.

7. Quality Management Systems:

To carry out the gap analysis against Quality Management Systems.

Handling change controls , deviations and CAPA's.

Carry out risk assessment in view of change in process / introduction of new product.

Raise and progress departmental change controls, deviations and CAPA's

Job Type: Full-time

Salary: 25, - 45, per month

Benefits:

Hea

Experience : 2 - 5 Years

No. of Openings : 1

Education : B.Pharma, M.Pharma

Role : Quality Assurance Officer

Industry Type : Manufacturing / Production / Quality

Gender : [ Male / Female ]

Job Country : India