Specialist - QA (Sterile)

at  Julphar

Ras al-Khaimah, رأس الخيمة, United Arab Emirates -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate30 Nov, 2024Not Specified02 Sep, 20242 year(s) or aboveTrackwise,EnglishNoNo
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Description:

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.
  • 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 (Biotech & Streile 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.
  • Assist in 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 2 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

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:2.0Max:7.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Software Testing, Clinical Pharmacy

Graduate

Proficient

1

Ras al-Khaimah, United Arab Emirates