Job Purpose Responsible for the cleaning, setting up and operation of manufacturing equipment as part of the process of compounding pharmaceutical creams, ointments, gels and liquids.

Duties And Responsibilities

• Complete G.M.P. documents, such as the Batch Record, cleaning & sanitizing logs, housekeeping logs and other documents / log records pertaining to manufacturing
• Follow safety rules/regulations and report any workplace injuries or accidents. Assist when required to improve equipment safety related procedures. Wash and sanitize compounding rooms and vessels
• Compounding batches as per SOP’s and Master Formulas. Report discrepancies and deviations in a timely manner to compounding lead hand or supervisor
• Dispense raw materials when required
• Perform accurate inventory transactions using SAP
• Maintain a clean and organized working environment. Familiar with 5S processes and Lean Manufacturing Concepts
• Participate and assist with continuous improvement projects and processes
• Work safely and accurately with a focus on completing tasks and documentation right first time
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Participate in and/or lead Non-Conformance Investigations
• Complete Corrective and Preventive Actions (CAPA’s)
• Initiate, and follow through with actions required to close Change Controls
• Participate in Internal, Customer and Regulatory Audits.
• Assist with the training of new compounders
• Perform start-up and shutdown procedures for all vessels
• Minor repairs to the facility and equipment where applicable
• Perform verification checks for equipment (scales, mixers, pH meters) used in manufacturing as per predefined time periods
• May be required to assist Validation or Pharmaceutical Technology staff with new formulations and scale ups
• May be required to assist with investigations where necessary
• Notify compounding lead hand and mechanic in a timely manner if equipment parts and compounding consumables are low in quantity
• 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

• University degree with 1-2 years of technical training experience or equivalent experience.
• Post-Secondary education in scientific discipline is preferred or a minimum of 5 years’ experience in a pharmaceutical environment
• Must possess the ability to function effectively in a team environment
• Must be able to actively listen and receive coaching and applicable training
• FL licence preferred
• Excellent math skills
• Proficient in MS Word, Excel, PowerPoint and Lotus Notes. Must be comfortable with use of tablets and trainable on associated programs (MES, SAP)
• Excellent verbal communication skills for interacting with personnel on a daily basis
• Previous experience in a pharmaceutical manufacturing environment
• Issues that may arise that have a GMP impact are evaluated at the time of occurrence in conjunction with the supervisor and QA.

Working conditions

• Overtime will be required to address priority items. This may be additional time during the work week and / or on weekends with last minute notice
• Shift work required which may include weekends
• Use of G.M.P garments and Safety Equipment (PPE) as required

Physical Requirements

• Physically fit, able to lift at least 25 kgs
• Stand for long periods of time
• Bending and “squatting” throughout the work day