Compounder

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
•    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

Direct reports

NA