Job Ref. ID:
AR Team Leader – Method Validation/Development
Research & Development
UNITED ARAB EMIRATES
UAE (RAK head office)
AR Team Leader – Method Validation/Development
Full Time Employment (Un-limited Contract)
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.
• 4 years Bachelor’s degree in in Pharmacy/ Chemistry or related Sciences.
• Master degree in Chemistry is recommended.
• At least 6-8 years’ experience in Pharmaceutical industry.
• Proven experience of specific regulatory discipline and principles, concepts, and governing Regulatory Affairs.
• 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.
• 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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