Operator III, Packaging - 2nd Shift

About WhiteCrow

We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house talent acquisition teams.

About our client

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

About the role

• With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling.
• Is qualified and capable of competently running all packaging equipment across the entire packaging department.
• Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.

As a Operator III, Packaging - 2nd Shift, you will be responsible for...

Packaging Operations:

• Being capable of competently running all packaging equipment across the entire packaging department
• Is qualified in both Filling and Labeling
• Ensuring that all equipment is running properly
• Executing processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.
• Requesting components, labels and inserts per the BPR
• Setting up packaging machinery; accurately sets equipment programming according to BPR's and SOP's
• Setting up, starts, operates, adjusts, troubleshoots and tears down packaging lines
• Executing Batch Production Record (BPR) and logbook documentation with detail and accuracy
• Accurately reviewing BPR's steps for completeness and accuracy
• Collecting samples from each batch and submits to QA for retained samples
• Demonstrating the ability to execute procedures and complete tasks in a compliant and safe manner

Equipment Cleaning:

• Conducting verification of line/equipment cleaning and documents per SOP
• Executing the procedures used to clean pharmaceutical packaging equipment and facilities
• Conducting Master Cleans and Surface Cleans

Continuous Improvement

• Identifying 6S opportunities and sustains the 6S process
• Assisting in troubleshooting process issues

Issues and Deviations:

• Identifying and reporting processing related issues to Packaging Supervisor and to Quality personnel.

Quality:

• Executing the required in-process product quality checks and documents accurately.

Teamwork and Collaboration:

• Demonstrating the ability to work in collaboration with others as a part of a team.

Training:

• Staying current on SOPs and cGMPs.
• Participating in training qualifier classes.

Safety and Compliance:

• Participating in safety teams, start-up discussions, incident debriefs, etc.
• Carrying out processing/packaging activities safely, as required, on a daily basis.
• Following all safety and compliance procedures and participates in required training.
• Adhering to all cGMP compliance/regulatory mandates and quality requirements.
• Ensuring compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies

Misc.:

• Other related duties as assigned to meet departmental and Company objectives.

What you already have...

Education & Experience:

• High school diploma or equivalent.
• 3 years of packaging experience

Knowledge & Skills:

• Knowledge of cGMP regulations and processes.
• Qualified in both Filling and Labeling
• Qualified and capable of setting up and running all machinery in the value stream
• Competent in Master Clean/Surface Clean
• Ability to sample batches
• Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation
• Ability to accurately and precisely record data and batch information
• Ability to work in both independent and team environments
• May become a certified trainer and provide certified training in one process
• Effectively interfaces with other department personnel if Senior level (4th level) isn’t available
• Ability to troubleshoot process issues
• Ability to Identify 6S opportunities and sustain the 6S process
• Ability to participate in Continuous Improvement projects
• Proficient in reading and writing English to understand work instructions and document results

Physical Requirements:

• Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
• Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
• Vision - ability to see details at close range (within a few feet of the observer).
• Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing