Associate, Quality Processes

Dr Reddy's Laboratories Ltd - Sandbox; Johannesburg; On-site; ZAR 350,000 - 550,000; Full time

Job summary

Dr. Reddy’s Laboratories Ltd - Sandbox in Johannesburg, South Africa invites an Associate, Quality Processes who is detail-oriented and analytical to join our pharmaceutical quality team.

You will oversee quality of equipment, systems, and processes to maintain compliance with industry standards. The role involves root cause investigations, internal audits for cGMP/FDA/ICH, data analysis for trends, CAPA management, stability program support, vendor audits, and contributing to continuous

Qualifications

• Bachelor's degree in a science field related to pharmaceutical product manufacturing and testing.
• 3-5 years of experience in a Pharmaceutical Quality role or Product Disposition.
• Strong knowledge of cGMP, FDA regulations, and ICH guidelines.
• Experience with quality management system elements.

Responsibilities

• Conduct and document root cause investigations for customer product quality complaints.
• Perform internal audits to ensure compliance with cGMP, FDA regulations, and ICH guidelines.
• Assist in analyzing data for trends and present findings in monthly quality reviews.
• Support the collection and summarization of data for annual product reviews.
• Contribute to stability program management, including study initiation, sampling, and data compilation.
• Collaborate with peer departments in managing CAPAs.
• Provide quality oversight for manufacturing floor operations as needed.
• Assist with vendor audits and qualification processes.
• Participate in root cause deviation investigations of non-complex issues.
• Support the development and improvement of quality processes and procedures.

Skills

Root cause analysis

Quality systems

cGMP

FDA regulations

ICH guidelines

Data analysis

SAP experience

Audit skills

Communication

Team collaboration

Education

Bachelor's degree in Science

Tools

SAP

Statistical software

Job description

At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Job Description

We are seeking a detail-oriented and analytical Associate, Quality Processes to join our team in Johannesburg, South Africa. In this role, you will collaborate with various departments to ensure quality oversight of equipment, systems, and processes in our pharmaceutical manufacturing facility. You will play a crucial role in maintaining and improving our quality standards while adhering to industry regulations.

• Conduct and document root cause investigations for customer product quality complaints in accordance with SOPs and industry guidelines
• Perform internal audits to ensure compliance with cGMP, FDA regulations, and ICH guidelines
• Assist in analyzing data for trends and present findings in monthly quality reviews
• Support the collection and summarization of data for annual product reviews
• Contribute to stability program management, including study initiation, sampling, and data compilation
• Collaborate with peer departments in managing Corrective and Preventive Actions (CAPAs)
• Provide quality oversight for manufacturing floor operations as needed
• Assist with vendor audits and qualification processes
• Participate in root cause deviation investigations of non-complex issues
• Support the development and improvement of quality processes and procedures

Qualifications

• Bachelor's degree in a science field related to pharmaceutical product manufacturing and testing
• 3-5 years of experience in a Pharmaceutical Quality role or Product Disposition
• Strong knowledge of cGMP, FDA regulations, and ICH guidelines
• Demonstrated experience with quality management system elements
• Excellent attention to detail and commitment to accuracy and completeness in decision-making
• Ability to work efficiently with strict timelines and adapt to changing priorities
• Strong interpersonal skills with a proven ability to work collaboratively in a team environment
• Capability to work independently and without direct supervision when required
• Excellent written and oral communication skills
• Experience and proficiency in root cause analysis tools and techniques
• Strong computer skills, including proficiency in statistical applications
• SAP experience preferred
• Flexibility to work occasional overtime and shifts as per business needs
• Analytical mindset with a focus on continuous improvement
• Familiarity with stability testing procedures and data analysis

Additional Information

All your information will be kept confidential according to EEO guidelines.