Job Title: Production Coordinator
Effective Date /
Last Modification Date: 28FEB17
Monitors, reviews, revises, prepares and trains on Standard Operating Procedures (SOPs) within the Packaging/Processing department, ensuring the SOPs reflect current Good Manufacturing Practices (GMP), Packaging procedures, and efficient work activities. Develops and maintains technical documents related to equipment and facility in the Packaging/Processing area.
Deviations Reports (DRs)/CAPAs and Standard Operating Procedures (SOPs)
- Reviews, revises and prepares SOPs for compliance to Good Manufacturing Practices and to reflect current work activities in packaging department
- Ensures SOPs for department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. In particular, SOPs in response to Bi-Annual Reviews, DRs, comments/audits by clients and regulatory agencies, change controls (CCs), new/modified equipment, committee findings (e.g. Compliance Meeting, Deviation Reduction Committee), and general changes in procedures
- Ensures SOPs are regularly reviewed and kept up to date with proper approvals
- Works closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
- Participates in committees (e.g. Compliance Meeting, Deviation Reduction Committee) and problem-solving teams
- Recommends, facilitates and monitors teams to solve DR problems or implements CAPA and increase efficiency in Operations
- Prepares SOP summary sheets
- Tracks status of in-process SOPs, training, and other activities
- Participates in departmental projects and cross-functional project teams
- Reviews proposals and timelines
- Liaises with departmental staff and other functional areas to meet project and team objectives
- Collects and analyzes departmental metrics and identify potential projects/solutions
- Participates in problem solving strategies
- Participates in operational opportunities within department by conducting detailed operational, value stream and financial analyses, interviewing key personnel, and observing operations as directed by the Management team.
Training and Process Improvements
- Prepares materials for informal (e.g. on-the-floor training) and formal training
- Assesses the learning styles and requirements of employees within packaging department and to design evaluation methods
- Co-ordinates, conducts and documents training sessions as required
- Works with departmental personnel to identify training and process improvements
- Gathers data to analyze process efficiency in the different work centers.
Other duties as required
Bachelors of Science (B.Sc.) or Bachelor of Engineering (B.Eng.) or related field
Minimum 1 year experience in the pharmaceutical industry, preferably in a packaging or processing documentation.
Previous training experience, preferably in the pharmaceutical industry (an asset).
Equivalent combinations of education, training, and relevant work experience may be considered.
Superior written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills. Proficiency with Microsoft Office (Microsoft PowerPoint, Microsoft Visio). Ability to work independently by taking on specific projects. In this role it is essential to perform shift work. Familiarity with Good Manufacturing Practices & Standard Operating Procedures an asset. Proficiency with the English Language.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Typically located in a comfortable indoor area; there may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Frequent need to distinguish among or interpret a variety of sensory inputs that require attention to decode and identify; frequent pressure from deadlines, production quotas, accuracy and similar demands.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.