|Job Ref. ID:
||Team Leader - Instrumentation
||Analytical Science & Technology (Quality)
||UNITED ARAB EMIRATES
||UAE (RAK head office)
||Full Time Employment (Un-limited Contract)
||The Team Leader – Instrumentation is responsible for supervision and technical direction over a team of engineers including total delivery of the instrumentation deliverables and services on time, within performance budget and meeting quality expectations. Perform advanced engineering work serving as a technical specialist for complex engineering assignments.
Work at this level requires extensive progressive experience in instrumentation engineering and involves utilization of project controls for cost control, scheduling and quality of projects. In this role your responsibilities include performing inginstrument related maintenance as per plan and procedures, ensuring adherence with the cGMP principles and maintain them in effective manner. You are primarily responsible for ensuring adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments.
The Team Leader – Instrumentation responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provide guidance and set standards in producing quality documentation, and provide timely and effective response and follow-through in issue resolution during installation and qualification activities. The instrumentation Team Leader will report to Analytical Science & Technology Manager and efficiently conduct all duties and responsibilities assigned and or delegated by the AS&T Manager.
|Key responsibilities & Accountability:
||• Accountable to supervise, lead, and direct the team to achieve the instrumentation deliverables and services on time, within performance budget and meeting quality expectations.
• Work as a technical specialist for complex engineering assignments to ensure the achievement of assigned goals and quality required.
• In this role you will be responsible to for maintenance as per plan and procedures, ensuring adherence with the cGMP principles and maintain them in effective manner.
• Ensure adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments.
• Participate in system design, prepare of test protocols, analysis of test results and preparation of summaries.
• Provide guidance and set standards in producing quality documentation, and provides timely and effective response and follow-through in issue resolution during installation and qualification activities.
• Confer with engineers, supervisor, and other technical workers to assist with equipment installation, maintenance, and repair techniques.
• Ensure proper division of work responsibility among the instrumental engineers, providing proper guidance & integration of work done, ensuring good, positive & healthy working nature among the team of engineers to ensure optimum productivity & efficiency.
• Manage Calibration & Qualification of all analytical equipment as per the calibration master plan.
• Follow-up the calibration procedure and perform the test / calibration by using Certified standard in the assigned labs.
• Review the protocols, reports & conduct technical review of previously generated data.
• Manage the preparation & issuance of RFQ’s, evaluation of vendor’s quotations, clarifications, Technical Bid Analysis etc. for all the required process aspects.
• Review of vendor’s documents, drawings, datasheets, specifications and calculations for all the required process aspects.
• Manage preventative maintenance and troubleshooting on all analytical instruments in QC, R&D & IPC and ensure proper equipment lifecycle management, following the equipment & quality SOP’s & follow safety measures in the workplace.
• Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity.
• Perform other related duties assigned by AS&T Manager and assist colleagues whenever necessary
• Responsible for training and mentoring staff; motivating them all for effective performance for the general growth of the company
• Identifies deficiencies in skills among team, and work to improve individuals’ capabilities through coaching, development, and training.
• Positively impacts the performance of individual team members by implementing and managing field support tools, including training programs and productivity initiatives.
|| - Education
||• Bachelor’s degree in Electronics Instrument Engineering/ Engineering.
• Masters degree is a definite advantage
|| - Experience:
||• Min 7-9 years of experience in Pharmaceutical Industry is required, with major expertise in chromatography and spectroscopy.
• Previous experience in a similar role is preferred for better fitment of this role.
• Proven experience ins using computerized maintenance system (SAP).
• Extensive progressive experience in instrumentation engineering and involves utilization of project controls for cost control, scheduling and quality of projects.
• Proven experience in qualifying analytical laboratory instrumentation (e.g. HPLCs, Spectrophotometers, FTIRs, etc.)
• Must be experienced in managing complex and sensitive operational challenges.
• Proven experience with computer system validations including leading, developing and implementing validation strategies and authoring required validation documents.
|| - Training:
||• In terms of Competency you are highly result oriented with strong sense of accountability & ownership.
• Motivated and highly organized professional and should be able to juggle competing priorities, with high level of integrity and professionalism.
• Strong organizational, planning and technical skills required.
• Excellent communication, interpersonal and presentation skill.
• In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping/
• Business acumen partnered with a dedication to compliance is essential for better fitment
• Having an analytical mind with ability to think diversely , resolve problems with outstanding planning skill to manage & expedite complexities of procedures and regulations
• Ability to work under pressure, plan personal and team workload effectively and delegate.
• You are a team leader with a proactive and collaborative approach.
||• Extensive knowledge in analytical instruments installations, trouble-shooting and service maintenance.
• Strong Knowledge with SOP writing, GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).