Sr. Specialist
Ras al-Khaimah, United Arab Emirates
Job Description
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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 equipments 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.
- In terms of competency, you are highly result-oriented with keen sense of accountability & ownership.
- High on compliance adherence, having strong diligence, initiative-taking and flexible.
- Effective communication, interpersonal, and collaboration skills.
- Should be having good learners mind to understand and grasp new learnings.
- Motivated, organized, focused & overall compliance.
- Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations.
- Ability to understand new learnings and implant in workplace.
- Bachelor I masters 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
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Job Detail
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Job IdJD1682218
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationRas al-Khaimah, United Arab Emirates
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EducationNot mentioned