Job Purpose

Cleaning & sanitizing packaging and compounding equipment and GMP working areas according to applicable SOP’s. May also be required to conduct duties of a Technician II, by operating filling and packaging equipment in a safe manner while maintaining compliance with cGMP and SOP requirements. Will be required to perform changeover and basic troubleshooting of Banding and Case Packaging equipment.

Duties And Responsibilities

Wash and sanitize miscellaneous and product contact parts for filling and compounding equipment.
Clean and sanitize GMP areas according to applicable SOPs.
Maintain miscellaneous and sanitization supplies.
Complete all applicable GMP documentation such as cleaning & sanitizing records and logs.
Assist with staging of components, raw materials and equipment parts.
Assist custodial staff with cleaning of the premises (if required).
Perform equipment set up as assigned.
Complete all GMP Documentation related to batch documentation, correctly and in a timely manner.
Complete all training assignments and maintain personal training records.
Participate in Non-Conformance Investigations.
Participate in Corrective and Preventive Actions (CAPA’s) investigations.
Participate in Internal, Customer and Regulatory Audits.
- Work with safety in mind with respect to all assigned tasks.
- Supply Packaging lines with components for packaging.
- Monitor and adjust fill weights throughout the operation ensuring minimal overfill.
- Perform line changeovers, set up and troubleshooting, as assigned.
- Prepare detergent and sanitizing agents with the correct dilution factor.
- Sanitize filling rooms as per standard operating procedure.
- Participate in Line Clearance Processes both inside filling rooms and in packaging.
- Operate filling units and cartoners as required.
- Troubleshoot rapidly and effectively to ensure minimal line downtime.
- Assist with training of new hires.
- Ensure all established procedures followed to prevent contamination of the filling room, bulk products and equipment.
- Support line leader to ensure smooth operation and execution of Packaging Work Order (PWO).
- Assist Line Mechanics as required.
- 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

Minimum Grade 12 education or equivalent
Experience in a pharmaceutical or related industry is an asset.
Mechanical aptitude. Experience with general tools and equipment including labelling, printers and manual material handling equipment is an asset.
Excellent math skills, must be able to add subtract, divide multiple, calculate average and percentages.
Good communication skills, written and verbal, in order to communicate effectively with operations personnel.
Fluent in English (verbal, reading and writing skills),
Excellent interpersonal skills.
Ability to use a computer including Microsoft, SAP and Manufacturing Execution Software (MES).
A good working knowledge and understanding of SOP’s required to be in compliance with cGMP’s.
WHMIS training an asset

Working conditions

Overtime will be required. This may be additional time during the work week and / or on weekends.
Unless pre-arranged the position is considered to be a “rotational shift“ based on 37.5 hours per week (bi-weekly rotational is only for continental shift).
GMP garments required to be worn within the manufacturing environment.

Physical Requirements

Ability to safely lift up to 20 lbs.
Operate lifting devices such as drum lifters, pallet trucks (manual and motorized) and pallet wrappers.
A significant time will be spent washing and sanitizing equipment resulting in exposure to water, cleaning agents and a high humidity environment.
Ability to able to stand for long periods of time. Also, bend, squat and walking throughout the day.

Direct reports

NA

SUN PHARMA

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