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Job Ref. ID:  50383 
Job Title: AR Team Leader – Method Validation/Development
Division: Research & Development
Work Location: UAE (RAK head office)
Job Type: AR Team Leader – Method Validation/Development
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: Team Leader – the role holder is responsible to manage, provide guidance and support to subordinate in ‎areas such as training and development in both technical and behavioral aspects. ‎ Ensure adherence to SOPs, cGMP and GLP requirements in analytical research department. You must have ‎excellent knowledge in analytical method development & method validation. Perform development process ‎in a scientific manner with good knowledge of reference pharmacopeia such as USP, EP and BP as well as ‎guidelines such as ICH and the all related activities. ‎
Key responsibilities & Accountability: • Responsible to adhere with the GLP principles and ensure that all laboratory activities are within safety ‎procedures.‎ • Ensure compliance with cGMP principles and SOPs. ‎ • Accountable for Method development, method validation and assist in formulation development from ‎analytical point of view or opinion.‎ • Review methods of analysis, development reports, validation protocols and validation reports and ‎ensure to be with highest quality and accuracy. Support in suggesting scientific specifications and ‎justification.‎ • Responsible for creating and updating SOP related to work demands. ‎ • Provide scientific and technical support on internal and external project teams.‎ • Work as a part of pre and post auditing stages preparation and responses.‎ • Conduct and attending regular meetings that are related to work status and projects timelines with ‎different stakeholders. ‎ • Contribute in assigning department objectives and KPI. ‎ • Provide recommendations and requirements of equipment, instrument and / or reagent required for ‎new Test Methods to enrich the lab area and system.‎ • Provide technical support within analytical research laboratories and other laboratories when needed.‎ • Maintain the equipment in working conditions and arrange calibration when required.‎ • Ensure that any data collected, analyzed and or shared while performing these duties is handled in line ‎with data protection and data storage and collection policies and protocols.‎ • Maintain the analytical data integrity, laboratory records, reports and logbooks.‎ • Contribute to the development of new products, evaluation tools/methods and improved systems.‎ • Responsible for writing SOP’s for equipment, cleaning and calibration to comply with cGMP & GLP.‎ • Responsible for training new team members and mentoring performance; motivating them all for ‎effective performance for the general growth of the company • Identify 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. ‎ • Preform any other work assigned by Manager and support colleagues whenever necessary.‎
   - Education • ‎4 years Bachelor’s degree in in Pharmacy/ Chemistry or related Sciences.‎ • Master degree in Chemistry is recommended.‎
   - Experience: • At least 6-8 years’ experience in Pharmaceutical industry.‎ • Proven experience of specific regulatory discipline and principles, concepts, and governing Regulatory ‎Affairs. ‎
   - Training:
Key Competencies: • In terms of competency you are highly result oriented with strong sense of accountability & ‎ownership.‎ • High on compliance adherence, having strong eye for process details.‎ • Motivated and highly organized professional and should be able to juggle competing priorities, with ‎high level of integrity and professionalism.‎ • Excellent communication, interpersonal, decision skills required • Must have a solution centric mind to understand issues and solve them within a stipulated time frame, ‎ability to understand new issues quickly and make scientific decisions. ‎ • Having an analytical mind with ability to think diversely, with outstanding planning and technical skills. ‎ • You must have excellent understanding of Pharmaceutical Business with ability to multitask and easily ‎adapt in a fast-paced environment.‎ • Ability to work under pressure, plan personal workload effectively and delegate.‎ • You are a team leader with a proactive and collaborative approach can take initiative and demonstrate ‎a dynamic approach to adapt with changing business need and environment.‎ 
Technical Competencies: • Should have handled similar role for a better fitment of this role. ‎ • Fluent in English is mandatory (communicating, writing and speaking). ‎ • Proficient user of office management software like MS Office (MS Excel and MS Word, specifically).‎ • Skilled in Science - Using scientific rules and methods to solve problems.‎ • Strong Knowledge in international guidelines such as ICH, USP, EP, BP and WHO. Scientific approaches ‎in method development and method validation. Different instrumentation and instruments trouble ‎shooting. And analytical trouble shooting. ‎ 


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