SR Executive/ Executive - QA

Alivira Animal Health; Thane; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Alivira Animal Health in Maharashtra seeks a seasoned QA/QMS professional to drive compliance and continuous improvement in pharma formulation operations. You will prepare and review SOPs, QMS documents, and annual product quality reviews, and support investigations into market complaints.

You will conduct internal audits, manage documentation validation, data submissions to RA, vendor qualification at Ambernath, and coordinate cross-functionally with QC, production, engineering and EHS to

Qualifications

• 7–10 years of pharma formulation experience.
• Experience in QA/QMS activities including SOPs, QMS documents, audits, and regulatory submissions.

Responsibilities

• Preparation/review of SOPs.
• Preparation & Approval of QMS documents.
• Review of Analytical data before release for distribution.
• Support of QMS activity.
• Support to investigations in case of market complaints.
• Conduct internal audits, report audit observations and follow up for compliance.
• Preparation & review of validation protocols and reports.
• Preparation & review of Annual Product Quality Review.
• Data submission as per RA requirements.
• Vendor qualification of RM & PM for Ambernath site.
• Reviewing qualification documents, calibration certificates, temp mapping data, validation docs related to utilities, equipment and instruments.
• Attend audits by customers/regulatory agencies and ensure observations are promptly addressed with CAPAs.
• Audit compliance.
• Coordinate with QC, Warehouse, Production, Engineering, EHS, HR for day-to-day activity.
• Ensure materials are properly tested and results recorded.
• Arrange stability samples for external lab analyses with documents & standards.
• Artwork approval with QC, Production and Marketing.
• Daily activities assigned by HOD.

Education

B Pharma

Job description

Role & responsibilities

• Preparation/review of SOPs.
• Preparation & Approval of QMS documents.
• Review of Analytical data before release for distribution.
• Responsible for support of QMS activity
• Responsible for support to investigation in case of market complaint.
• Responsible for conducting internal audits, reporting audit observation and follow up for compliance.
• Preparation & review validation protocols and reports.
• Preparation & review of Annual product Quality review.
• Responsible for Submission of data as per requirement of RA.
• Responsible for vendor qualification of RM & PM for Ambernath site.
• Reviewing of qualification documents, calibration certificates, temp mapping data, validation documents related to utility, equipments and instruments.
• To attend audit customer/regulatory agencies ensure any observations received if any are promptly acted upon and appropriate corrective and preventive actions are identified and implemented.
• Responsible for audit compliance.
• Co-ordinate with other department QC, Warehouse, production. Engineering, EHS, HR, for day to day activity.
• Ensure material appropriately tested and result recorded
• Arranging stability samples to send for external lab, for analysis along with relevant documents & standards.
• Artwork approval in coordination with QC and production and Marketing.
• Responsible for daily Activity assigned by HOD.

Preferred candidate profile

B Pharma . Having 7 to 10 years experience in Pharma - Formulation