Pharma Quality Process Specialist

Dr Reddy's Laboratories Ltd - Sandbox; Calgary; On-site; CAD 90,000 - 120,000; Full time

Job summary

Dr. Reddy's Laboratories Ltd - Sandbox in Canada seeks a Quality Assurance professional to oversee pharmaceutical manufacturing processes and ensure compliance with cGMP, FDA regulations, and ICH guidelines.

You will lead root cause investigations, internal audits, and data analysis for product quality, CAPAs, and annual reviews, collaborating across Quality, Manufacturing, and Technical Services. This role requires a Bachelor’s in a science field and 5+ years of QA experience, with strong

Qualifications

• Experience in an in-process quality role in pharmaceutical manufacturing.
• 5+ years in Pharmaceutical Quality/Product Disposition.
• Ability to work under strict timelines and changing priorities.
• Strong interpersonal and teamwork skills.

Responsibilities

• Conduct root cause investigations of customer product quality complaints per SOPs.
• Perform internal audits to ensure cGMP, FDA regs, ICH guidelines.
• Collect and summarize data for annual product reviews or other purposes.
• Support stability program management and data analysis.
• Assist with vendor audits and qualification.
• Provide quality oversight for day shift manufacturing operations in absence of first shift personnel.

Skills

Attention to detail

Team collaboration

Strong communication

Time management

Data analysis

Root cause analysis

Education

Bachelor’s degree in a science related to pharmaceutical manufacturing

Tools

SAP

Job description

Dr. Reddy's Laboratories Ltd - Sandbox in Canada seeks a Quality Assurance professional to oversee pharmaceutical manufacturing processes and ensure compliance with cGMP, FDA regulations, and ICH guidelines.

You will lead root cause investigations, internal audits, and data analysis for product quality, CAPAs, and annual reviews, collaborating across Quality, Manufacturing, and Technical Services. This role requires a Bachelor’s in a science field and 5+ years of QA experience, with strong