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Position: Permanent Full-Time Production Supervisor. On site. Salary: $42.50 hourly/40 hours per week. Starts as soon as possible. Working hours from 09:00 to 17:00. Benefits: Health benefits, Financial benefits, Other benefits. 1 vacancy.
Overview:
Languages: English.
Education:
Secondary (high) school graduation certificate.
Experience:
2 years to less than 3 years.
On site.
Work must be completed at the physical location. There is no option to work remotely.
Responsibilities:
Tasks:
Recommend measures to improve productivity.
Resolve work problems, provide technical advice and recommend measures to improve productivity and product quality.
Investigate deviations in yield associated with critical process steps , determine their impact or potential impact on the result quality of affected batches.
Supervise, co-ordinate and schedule (and possibly review) activities of workers.
Establish work schedules.
Prepare production and other reports.
Recommend measures to improve productivity and product quality.
Provide information for maintenance plans to ensure that maintenance and production objectives are met.
Co-ordinate work activities with other departments, including but not limited to:
Review Batch Production Record, deviation, investigation and OOS reports before the batch is released by quality team.
In charge of production documents control before quality team review and Health authorities on site audit.
Coordinate with quality control team to qualify hoods and cleanrooms based on SOP, put air samples into cleanrooms, mapping the worst and best spot for microbial sampling.
Train staff/workers in job duties, safety procedures and company policies, including but not limited to:
Train and supervise operators to clean the hoods and cleanrooms based on approved and validated cleaning procedures from quality assurance team and document it.
Train and supervise operators to sample from specific batch and document it into master batch record.
Supervise operators for daily calibration of standard weights, scales and document it.
Requisition or order materials, equipment and supplies.
Set up machines and equipment.
Good Manufacturing Practices (GMP), including but not limited to:
Good knowledge of different APIs chemical structurer , density, particle size to determine the primary and secondary packing size.
Knowledge of licensing regulations, including but not limited to:
Proficient in ICH guidelines Q7 for Active Pharmaceutical Ingredients ( APIs ).
Proficient in FDA eCFR 21 regulations for APIs.
Proficient in Health Canada Drug Establishment License requirement for APIs sampling, re-labelling and re-packaging activities.
Label, file and retrieve documents, including but not limited to:
Verify all the critical information from master batch record during the re-packaging process.
Document and report deviations from specifications and tolerances.
Supervise and investigate any label damages, package damages, APIs spillage, document it and report to quality team for review.