Manager, Site Calibration

Job purpose

This position is responsible for the managing and co-ordination of the Laboratory Metrology Team as well as the oversight of the site-wide calibration program supporting manufacturing and packaging operations in compliance with Taro SOPs, Health Canada and FDA requirements. The position will also be responsible for the management of implementation of CSV and non-CSV equipment for the Quality Control laboratory.

Duties and responsibilities

• Manage and lead staff including: setting objectives, career development, performance reviews, ongoing coaching and routine staff meetings.
• Manage or author unplanned deviations in relation to metrology properties of laboratory equipment.
• Responsible for day to day operations of the Laboratory Metrology Team by coordinating and facilitating priorities, organizing weekly events to meet requirements and communicating effectively to key areas.
• Plan, schedule, organize and monitor workload optimally to ensure activities are performed on a timely manner in accordance with the laboratory calibration schedule.
• Manage equipment utilization metrics and report system utilization to justify system replacement or upgrades.
• Manage all Quality Control work orders to ensure completion in a timely manner.
• Liaise with all vendors to ensure continuous delivery of the services. 
• Effectively manage all Quality Control analytical equipment qualification, calibration, preventive maintenance and repair program in a timely manner and in compliance with company Global Quality Policies, Standard Operating Procedures and regulatory requirements.
• Oversee calibration activities in the manufacturing and packaging operations as well as ensure calibrations are being conducted in accordance with the site calibration schedule and in compliance with company and regulatory requirements.
• Manage development of calibration procedures for new equipment at the site or update pre-existing procedures to ensure proper and efficient verification.
• Provide guidance, direction, effective solutions and technical resources to the site calibration program as needed.
• Work independently and complete all GMP Documentation (calibrations, qualifications, and PMs) correctly and in a timely manner.
• Manage the team to ensure complete calibrations and PMs; and assist with instrument qualifications (IQ/OQ/PQ) in a timely manner.
• Assist in data interpretation and associated report writing
• Provide effective solutions by effective communications and developing relationships through excellent customer service.
• Plan and make sure supplies and equipment are available site-wide on time.
• Participate in and/or lead Non-Conformance Investigations.
• Complete Corrective and Preventive Actions (CAPA’s) on time.
• Initiate, and follow through with actions required to close Change Control Records.
• Participate in Internal, Customer audits and Regulatory inspections.
• Other duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s Degree in Science, or related discipline
• Minimum 10 years’ of calibration, preventative maintenance and equipment repair experience
• Experience in coordinating and managing team activities
• Advance understanding, troubleshooting and application of analytical and support instruments and equipment in pharmaceutical laboratory
• Resolution of problems associated with a wide variety of calibration challenges and issues that can be more than routine in nature from errors in lab equipment, preventative maintenance program, repairs or incomplete equipment qualification
• Problem solving associated with dealing with multiple departments simultaneously as well as working with external contractors
• Sound understanding, troubleshooting and application of equipment in manufacturing and packaging operations
• Self-driven professional with demonstrated ability to work with little direction, make independent decisions and seek clarification and directions when needed
• Excellent and effective communication and problem solving skills
• Proficiency with various instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC)
• Knowledge of applicable software
• Good organizational skills, multi-tasking ability
• Good working knowledge of GMP’s

Working conditions

• Generally, fairly pleasant surroundings 
• Occasional exposure to higher than normal noise levels, frequent exposure to various chemicals used in the testing of raw materials, components and finished products 
• Occasional exposure to unpleasant odors resulting from testing procedures 
• Fair level of temperatures 
• Mixture of standing and walking, some light lifting and/or moving of instruments with the aid of a cart

Physical requirements

Office based OR Hybrid role

Direct reports

3 Calibration Analysts