Head of Technical Operations
6 days ago
Megsan Labs – A Tentamus Company is a leading US-FDA approved business, which provides analytical testing services to pharmaceutical and related companies. The services comprise elemental impurity studies, E&L studies, method development & validation and microbiological testing.
Purpose of the Role:
To help smooth functioning of testing activities in multiple food matrices, gain customer through timely deliverables and sustainable compliance.
Primary Responsibilities
Operational
Ensure thorough evaluation and response to client queries on method feasibilities, requisites and communicate the key assumptions of scope work.Ensure that all project agreements, scope of work are thoroughly drafted with required details.Ensure that all the pre-requisites, including samples, standards, facilities, instrument, reagents and resources are made available, prior to initiation of work.Ensure the team reviews the contract appropriately and facilitate the availability of prerequisites on- time to execute projects.Approving the analyst’s qualification and ensure prior to allocation of independent work.Review and Approve the documents as applicable (Manuals, Standard Operating Procedures, Standard Test Procedures, Protocols, Reports etc.,).Guide teams in conflict resolution, clarity in scope of work in execution of projects.Review of project progress and resource allocation to facilitate smooth flow of projects.Review and monitor instruments performance and ensure that all instruments and equipment are covered under AMC and are maintained in well calibrated and functional state.Devise process improvement and productivity improvement plans and identify facility and capabilities up gradation.Identify and drive key areas of business focus.
Human Resource
Ensure the smooth coordination between teams and team members and facilitate for the resolution harmonization across the facility.Identify the resource required and facilitate for the appropriate approvals.Selection and hiring of associates for the operation of services as needed.Approval of leaves on basis of work load and its management.Conducting the performance management and providing feedbacks timely.
Client Management
Support teams to understand the scope of work prior to acceptance/initiation of project.Participate in client calls to understand the scope of work and to facilitate finalization of projects.Co-ordinate with BD team to understand the client needs and direct client queries to right department for further evaluation.Ensure the team perform thorough review of contracts appropriately prior to its acceptance.Participate in client communications to resolve any technical issues or unforeseen delays in project timelines.Ensure the project is executed and delivered by adhere to mutually agreed timelines.Take action to avoid delay or inform client well in advance and seek permission to extend due date.Review the data and interpretation of results and appropriately communicate with clients and drive the project.Ensure to deliver all the findings of studies and analysis are communicated to clients in appropriate form.
Quality Management
Ensure that all the activities are performed in accordance to written procedures and necessary procedure controls are established as per regulatory requirements.To perform periodic review of existing procedures and processes and suggest quality improvement plans.Ensure the team to adhere to quality systems and supervise system periodically.Participate in the customer audits and certification regulatory authority audits, as needed.Execution and implementation of necessary CAPA as per the requirement.Attend the management review meeting and provide the report about the performance of the department to management during the meeting.Strive to ensure compliance of lab activities to all applicable regulations.
Business Objective
Monitor daily operations of Pharma, Physical characterization, Trace, and Microbiology to align all deliverables to committed timelines.Measure each activity in terms of cost and/or time (if an activity can’t be measured it can’t be improved or managed).Devise improvement plans for all operations in-line with client expectation.Identify/develop suitable new capabilities to suit client requirements and business needs.Report internal & external customers’ opinions to the management.Estimate requirements on monthly / quarterly basis and indent for chemicals & consumables in sufficient advance timeMake business plans, communicate targets to the team & business development team.Contribute to elevate the brand image of organization with strategic business improvement plans in co-ordination with BD team.Any other activity assigned by Reporting Manager/ Management.
Safety Health and Environment
Ensure that all employees delivery duties under safe environment.Ensure the safety practices and procedures are adequately followed and necessary personnel protective equipment as desired by nature of job are in practice.Provide safety devices in consultation with management.Devise safe handling and disposal practices.Devise and develop suitable procedures to handle potent and controlled substances.Ensure that relevant procedure for handling of chemicals, reagents and solvents updated with current safe practices and procedures.
Secondary Responsibilities
Get test methods validated on need basis.Ensure master calibration and standards’ records are maintained and verify critical calibrations.Develop and validate new cost effective methods in testing & training.Provide cross functional / divisional training.Motivate team, celebrate successes; listen to the analysts.Empower team members (objective is to create an organization which is customer responsive and proactive).Educate analysts on cost of rework (do it right the first time), customer time, customer emotional costs, customer out-of-pocket expenses, cost of incremental marketing (lost vs. new customers).Motivate analysts to upkeep time protocols, to be friendly and courteous evidenced by their smiles and cheerfulness.
Essential Qualification
Essential Experience: M Sc-Food Science. M.Sc-Food Technology, B.Tech-Food Technology, M.Sc-Chemistry or Analytical Chemistry with 20+ years of experience in Food testing services. Out of the total experience at least 10 years in CRO is preferred.
Requirements and skill set:
Work experience as Head Technical/ instrumentation, preferably within Food CRO industryLeadership skills with the ability to set and prioritize goalsAnalytical mindsetCommunication and writing skills.Data driven thinkingExcellent leadership, communication, interpersonal and customer service skills.Knowledge on regulatory/ certification body requirements
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