Specialist - Batch Release

Julphar; Ras Al Khaimah; On-site; AED 100,000 - 140,000; Full time

Job summary

A leading pharmaceutical company seeks a Quality Assurance professional to manage batch records and compliance with cGMP regulations. The role involves auditing processes, updating trackers, and working closely with other departments to ensure quality standards. Candidates must hold a Bachelor's in pharmacy and have 2-4 years of industry experience.

Qualifications

• Advanced knowledge in cGMP.
• 2-4 years of experience in QA roles.
• Well-disciplined while dealing with stakeholders.

Responsibilities

• Review and audit completed Batch records at all process stages.
• Update the daily tracker for observations and follow up on corrections.
• Issue batch release certificates for final approval.

Skills

Task management

Adaptability

Accountability

Complexity handling

Education

Bachelor’s degree in pharmacy

Job description

Detailed Job Description

• Responsible for reviewing and auditing all completed Batch records at all process stages for all dosage forms & to ensure the conformance as per the requirement of cGMP and related SOP’s
• Responsible for reviewing Batch Documents as per the related checklist of the SOP QA-00-009
• Responsible for checking the details of vendors used in the batch as per Approved vendor list.
• Responsible to update the daily tracker for the observations identified and follow up with related departments for corrections in Manufacturing/Packaging documents.
• Responsible to ensure any deviations/investigations occurred in the batch & documented the deviation/investigation details prior to entry of batch record compliance in SAP
• Responsible to provide the details of batches entered in SAP as a part of compliance at the end of the day for final release
• Responsible to issue the batch release certificate for final batch approval.
• Responsible to perform QMS actions.
• Perform any other work assigned by the Team Leader/ QA Manager.
  
  

Core Competency

• Must be able to manage tasks and priorities and easily adapt to changing situations
• Flexible learning abilities
• Responsible and Accountable
• Able to handle complexity at system level/ tasks level
  
  

Qualification/Functional Knowledge

• Advanced knowledge in cGMP
• Proven understanding and well-disciplined while dealing with all stakeholders.
• Excellent knowledge of reporting procedures and record keeping.
• Bachelor’s degree in pharmacy
• 2-4 years of experience