Sr. Specialist - QA (Sterile)

at  Julphar

POSITION SUMMARY :

• In this role you will be responsible to adhere and ensure compliance cGMP principles and maintain them in effective manner.
• Deviations investigation
• Participate in the media fills.
• Preparation of Process /Facility/Equipment Risk assessments
• Should have Quality mindset in the process and procedural review.
• Regulatory Audit exposure and Participate in Internal and External Audit programs.
• Perform in-process quality check activities according to SOP in production / packaging departments (Sterile Injectable) in complying with cGMP principles and captures test results in batch records.
• Check the required tests for all products during production / packaging process.
• Inspect and check incoming materials by confirming specifications and return unacceptable materials.
• Revise all documents for in process control and perform a quality review of logbooks.
• Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system.
• Preparation of Annual Product Quality Review reports.
• Ensure the in-process check equipment’s are adequately calibrated and functions properly.
• Perform and check the line before start (production/packaging) and give the clearance for the work.
• Check all material required for manufacturing steps (production/packaging).
• Maintain accurate records and perform tests on all activities conducted in the plant.
• Plan and assign daily job duties to fulfil the plan.
• Accomplish quality and organization goals by completing related results as needed.
• Maintain safe and healthy work environment by following standards and procedures and complying with regulations.

QUALIFICATIONS, KEY EXPERIENCES / FUNCTIONAL KNOWLEDGE REQUIREMENTS:

• Bachelor I master’s degree in pharmacy
• Knowledge on EU Annex-1
• Minimum 3 years in quality operation in Sterile manufacturing
• Good Computer knowledge and knowledge of QMS system “Agile, Trackwise, Ampelogic”
• Proficient in English.
• Quality and Business decisions taker
• Good Knowledge and command on cGMP
• Risk Assessment knowledge

Please refer the Job description for details