Hybrid Compounder (Continental) (Brampton, CA) chez Sun Pharmaceutical Industries
Sun Pharmaceutical Industries · Brampton, Canada · Hybrid
- Senior
- Bureau à Brampton
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