Associate I, Quality Operations

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.

Responsibilities:

• The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.
• Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.
• Communicates to multiple departments and supervision to provide timely process and issue updates.
• Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.
• Participates in reviews and structured processes for continuous improvement.  

Quality Operations:

• Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.
• Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.
• Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.
• Follows internal processes related to controlled substances.
• Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials
• Collects and appropriately labels packaging retain samples, and submits to the archive storage
• May execute computer data entries in CME, JDE, LIMS, and/or department databases.
• Collects retain samples and performs sample evaluation for Annual Product Review.
• May backup third party product review/release.
• Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.

Non-conforming events:

• Responds to and escalates events identified during production to Quality Management.
• Participates in investigations with the Rapid Response Team as needed.

Process Improvement:

• Collaborates with Manufacturing and Quality partners to identify and implement improvements.

Compliance:

• Conducts GMP walkthroughs of facilities

• Learns how to perform in-process audits to identify adherence to SOPs and BR requirements.
• Actively participates in training events, and maintains currency with assigned training requirements.

Safety:

• Follows all procedures to ensure a safe and compliant work environment.

Requirements:

Education & Experience:

• High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)
• Ability to communicate and work with teams.
• Attention to detail.
• Strong documentation skills.
• Ability to read and interpret SOPs and function within the scope of procedures.