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Job Ref. ID: |
50375 |
Job Title: |
Process Lead - Engineering Oversight |
Division: |
QA Compliance |
Country: |
UNITED ARAB EMIRATES |
Work Location: |
UAE (RAK head office) |
Job Type: |
QA - Process Lead - Engineering Oversight |
Employment Type: |
Full Time Employment (Un-limited Contract) |
Job Description: |
Purpose: |
Process Lead - Engineering Oversight primary responsibility will be management of the Engineering Compliance activities, review the procedures and ensure processes are in a GMP compliant manner.
The role holder will support on Julphar activities final review of Engineering Documentations & SOPs Breakdown and out of calibration documents. Review & ensure all site layouts for compliance with GMP standards. As well as responsible for closure of CAPA actions after performing independent review to ensure proper closure for engineering activities.
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Key responsibilities & Accountability: |
Key responsibilities & key result areas
● The role holder is responsible for review Engineering Documentations & SOPs / Breakdown and out of calibration documents
● Review all site layouts for compliance with GMP standards
● Review calibration certificates for compliance and guide the team where deviation is needed
● Responsible for closure of CAPA actions after performing independent review to ensure proper closure for engineering activities
● Responsible for reviewing & approving extensions as per the LSOP for CAPA Management for engineering activities
● Participate in cross functional team for Deviation management process
● Weekly reporting for Engineering compliance state
● Create Continuous Improvement Framework for Engineering Compliance.
● Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks.
● Accomplish goals and organization mission by completing related results as needed.
● Identify deficiencies in skills among sales associates managed, and work to improve individuals’ capabilities through coaching, development, and training.
● Drive the relevant soft skills including continuous improvement, and team building activities.
● Maintain and promote a teamwork environment with effective and clear communication amongst colleague.
Core Competency
● Solid Technical knowledge with strong implantation, and influencing skills.
● High on communication and collaboration, having an ability to manage multiple stakeholders at a time
● In terms of competency you are highly result oriented with strong sense of accountability & ownership.
● Strong communication, interpersonal, and implementation skills required.
● In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping
● Must be able to manage tasks and priorities and easily adapt to changing situations.
● Ability to create cross functional relations and manage conflicts.
● Problem Solving and high agility on taking right scientific decisions
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Qualifications: |
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- Education |
● 4 years Bachelor in electrical/ Mechanical /Mechatronics Engineering/ any discipline in same field.
● Master degree is a plus.
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- Experience: |
● At least 6-8 years of experience pharmaceutical industry sector with strong knowledge in utilities
● Prior experience in handling similar role will ensure better fitment.
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- Training: |
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Key Competencies: |
● Excellent command in English (Communicating, writing and speaking).
● Proficient in MS Microsoft office and computer knowledge.
● Proven track record in systems initiation and KPI design
● Proven experience in project implementation in GMP environment. |
Technical Competencies: |
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