Junior Team Member - QA

Division

Department

Employment Type

Job Purpose

Coordinate for audits and track the compliance of non-conformances, ensure implementation of QMS system, review all master documents and APQR data and perform timely release of batches manufactured at CMO/PTL sites to deliver quality products and meet regulatory compliance

Accountabilities

1. Responsible for evaluation of change request initiated by Unit in software. Perform scheduled activities related to change request as per procedure mentioned in respective SOP.
2. Responsible for preparation and review of investigation of out of specification, out of trend, deviation, Market complaints and CAPA (Inhouse and Global) through TrackWise software based on the roles and rights provided in the System.
3. Responsible for preparation, review, and handling of Annual Product Quality Review of products as per define frequency.
4. Responsible to ensure appropriate corrective and preventive actions based on the results of the investigations are identified and implemented at site.
5. Responsible for preparation of various trends of Quality management system i.e., Deviation, market Complaint, and CAPA etc.
6. Responsible for preparation of monthly Quality Management Review meeting document.
7. Responsible for preparation of monthly Quality Matrices Score Card of site.
8. Responsible to review executed and master batch records of products.
9. Responsible for handling of FMECA & Product Recall activity.
10. Responsible for compliance to audit observations and cGMP requirements.
11. Responsible for daily oversight from different department and compliance of the same.

Education Qualification

B. Pharmacy

Relevant Work Experience

4-7 years of experience in quality assurance of a pharmaceutical organization with the knowledge of oral solids, oral liquids, external and sterile products processing and controls, QMS, cGMP

Competencies/Skills

Job Location

Baddi

Shift Hours