Urgent Requirement For QA - Validation & QA - QMS @ Amneal Pharma

We are looking for competent, dynamic and motivated candidates for below positions for QA - Validation & QA QMS department for Amneal Pharmaceutical Pvt. Ltd (Injectable units, Pipan Plant, Ahmedabad)

INJECTABLE REQUIREMENTS:

Quality Assurance (Validation & QMS) Department- (Injectable/Parenteral Unit)

1) Designation: Executive/ Sr. Executive/ Assistant Manager
Department : Quality Assurance (QA) Validation

Qualification: B. Pharm / M. Pharm / M. Sc

Job Location : Sanand, Ahmedabad
Total Experience: 05 to 09 years in QA department in sterile/ injectable manufacturing facility.

Job Description:

• Execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities
• Preparation and review of Validation/ Qualification protocol and report
• Preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system
• Conduct sampling activity as per the protocols (Process validation and clearing validation etc.)
• Assessment of Change Control, Deviation, CAPA, Investigation etc.
• Review of URS, DQ and vendor/ supplier’s documents related to qualification.

2) Designation: Executive/ Sr. Executive/ Assistant Manager
Department : Quality Assurance (QA) – QMS

Qualification: B. Pharm / M. Pharm

Job Location : Sanand, Ahmedabad
Total Experience: 05 to 09 years in QA department in sterile/ injectable manufacturing facility.

Job Description:

• Review of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment.
• Review of Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions.
• Performing investigation of Unplanned deviations, Out of specification, Out of Alert Limit, Computer system incident, Environmental Excursions.
• Tracking and closure of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment, Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions within allotted target date.
• Review and closure of effectiveness check of actions.
• Performing investigation of Market Complaints.
• Performing assessment of received other site CAPA and tracking closure.
• Evaluate CAPA and notifying to other sites.
• Preparation and review of SOPs.
• Performing self inspection of departments.
• Performing Product failure investigation, handle the mock recall and product recall.
• Review of Artworks and tracking implementation of the Artworks.
• Preparation of presentation for QRB, Quarterly meeting.

Candidate with good communication & interpersonal skills, computer knowledge and understanding of regulatory requirement will be preferred.

Interested candidates who are interested to attend interview, can share their CV on below mail ID with subject line “Application for INJ QA – Validation / QA - QMS : ajaykumar.pandey@amneal.com or can submit their details by given link: https://forms.office.com/r/Wr3ULz9cE6

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