Operation Supervisor

PROFILE

A pro-active, reliable manager with a commitment to teamwork, an ability to work under pressure, communicate clearly with peers, senior management, and customers and a commitment to continuous improvement within the Pharmaceutical and Food industry.

PROFESSIONAL EXPERIENCE

Mondelez International (Cadbury Chocolate) Jul 2014-Present

Operation Supervisor

Manage the activities of union operators to ensure timely achievement of department goals

Plan, organize and communicate daily work schedules to meet departmental and Site requirements

Responsible for SAP team training, inventory count

Responsible for implementation of IL6s projects, team training on IL6s process

Identify and take action to improve the quality, safety and efficiency of the processes

Monitor work performance to ensure schedule conformance and address daily production issues

Track and report daily, weekly and monthly performance of functional department to monitor progress toward achievement of site and divisional KPIs

Motivate and mentor all staff, provide regular and timely performance recognition/counseling, and encourage on-going skills and competency development

Consistently champion quality-focused manufacturing processes by being present in the work area, monitoring work performance and compliance with GMP/cGMP & SOP requirements

Ensures appropriate training is completed. Advocate safe work practices and ensure work is performed in compliance with Environmental, Health & Safety requirements

Complete regular work area safety audits, including equipment risk assessments, review of SOPs and safety policies, job hazard analysis and physical demands analysis

Manage attendance in SAP system

Developing training programs, supervising and coaching staff

Managing projects and attending to follow through

Teva Canada Pharmaceutical Ltd Jun 2012-Apr 2014

Operation Supervisor

Manage the activities of thirty two direct reports to ensure timely achievement of department goals

Responsible for site preparation for Health Canada and FDA audit

Responsible for site compliance to quality systems, quality procedures, policies, regulatory requirements (Health Canada and FDA) and client requirements.

Managed all site validation activities, and manage Quality Assurance resources to ensure continued validation effectiveness

Reviewed and updated SOP's according to company policies and GMP regulations

Implemented entire quality system compliant with Health Products and Food Branch Inspectorate (HPFBI), Food and Drug Administration (FDA) Quality System Requirements in highly technical, regulated environment, in both manual and automated settings

Create Emergency preparedness procedure as per government regulatory requirements

Provided GMP training for manufacturing and packaging operators to transform internal processes, procedures, and culture to achieve optimal operational performance while achieving and maintaining compliance to regulatory requirements

Coordinate investigations, corrective and preventive action (CAPA) recommendations related to finished products and packaging components in Trackwise system

Interview, selection and orientation of new hires/transfers to the department. Provide interim performance monitoring and feedback for staff. Manage the effective deployment and utilization of staff to meet Packaging targets

CIBA VISION (Novartis Canada) Sept 2009- Jun 2012

Production Supervisor (Aseptic Manufacturing)

Managing eleven production operators who are responsible for manufacturing prescription and OTC pharmaceutical products

Participated in multiple FDA inspections

Approving protocols and overseeing all employee issues

Responsible for production process and product quality outputs

Provide technical, customer relations and personnel management for major programs/ projects

Provide customer service to all internal and external clients in a cost effective manner through continuous improvement initiatives

Ensure the competencies, effectiveness, compliance and safety/ health of the manufacturing team meet the policies/requirements and all training files are up to date

Provide input into the production schedule and prioritizing work according to production schedule on a daily basis to meet customer demands

Initiate deviation report through the Trackwise system. Write NCR/CAPA process investigations. Make sure the CAPAs are closed in a timely manner

Investigate root cause for non-conformance or OOT/OOS products

Participate in change control meeting for CR approval, red line SOPs and controlled documents

such as work order to implement corrective actions

Manage attendance in ADP system

Interact with computer controlled equipment HMI to control the process flow

Reduce TPC, create a problem solving culture through Kaizens and process improvement initiatives

Interacts with contract manufacturers and suppliers to establish relationships for quality oversight and inter-company communication to maintain compliant documentation and processes

Complete regular work area safety audits, including equipment risk assessments, review of SOPs and safety policies, job hazard analysis and physical demands analysis

APOTEX INC. Jun 2003- Apr 2009

Project Leader (Research and development)

Plan, organize and communicate daily work schedules to meet R&D daily schedule

Monitor work performance to ensure schedule conformance and address daily R&D issues

Monitor work performance and compliance with GMP/cGMP and SOP requirements

Ensure appropriate training is completed

Advocate safe work practices and ensure work is performed in compliance with Environmental,

Health & Safety requirements

Responsible for SAP team training in R&D department and training roster updates

EDUCATION

Nutrition and Food (BASc) 2007

Ryerson University

Engaged in food and health research

Gained the scientific principles of food manufacturing practices, law and ethics that governs the industry, while integrating GMP, SOP, QC & QA, HACCP and FDA compliance

Learned product development, recipe analysis, quality assurance and quality control

Gained principals of foodservice management, consumer affairs, and marketing methods

Topics discussed included organic and general chemistry, biology, nutrition and growth, physiology, physical and chemical methods of control, food microbiology

INDUSTRIAL PHARMACEUTICAL TECHNOLOGY 2003

TIPT (Toronto Institute of Pharmaceutical Technology)

Acquired hands-on experience in compounding, tableting, encapsulation and coating

Understanding the scientific principles of the processes and the ability to identify and correct defects

ADDITIONAL INFORMATION

A strong commitment to customer service

Computer proficiency with Microsoft Word, Excel, Lotus Notes, Access, Power Point and Outlook

Improvising/adapting and applying creative solutions to roadblocks

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