Zydus Biologics Job Opening: Quality Control / Quality Assurance Roles
Position Name: Quality Control / Quality Assurance
Organization: Zydus Biologics
Location: Biotech Park, Ahmedabad, Gujarat, India
Industry: Pharmaceuticals
Qualification: M.Sc. in Biotechnology or Microbiology
Experience: 3 to 6 years
Salary: Not Available
About Zydus Biologics
Zydus Biologics is a leading multinational pharmaceutical company based in Ahmedabad, Gujarat. As a part of Zydus Cadila, the company specializes in the manufacturing of generic drugs and has been recognized as a top player in the pharmaceutical industry, ranking 100th in the Fortune India 500 list in 2020. With a global presence, Zydus Biologics is renowned for its excellence in biotechnology and life sciences.
Open Positions: Executive / Senior Executive in QC and QA
Zydus Biologics is hiring for Quality Control (QC) and Quality Assurance (QA) positions at their Ahmedabad facility. This opportunity is ideal for professionals with a background in biotechnology or microbiology, who are looking to advance their careers in a globally recognized organization.
1) Quality Control (QC) Chemical
Qualification: M.Sc. in Biotechnology
Experience: 3 to 6 years
Key Responsibilities:
- Conduct Protein Analysis, Instrumentation, Molecular Biology, and Bioassay.
- Review and ensure accuracy of test reports, calibration reports, logbooks, and records related to protein analysis.
- Investigate incidents, deviations, and out-of-specification (OOS) results during laboratory analysis.
- Maintain and manage lab protocols and standards, adhering to good laboratory practices (GLP).
2) Quality Control (QC) Microbiologist
Qualification: M.Sc. in Microbiology
Experience: 3 to 6 years
Key Responsibilities:
- Conduct Environmental Monitoring, including air sampling, surface monitoring, and personnel monitoring.
- Perform critical tests such as Water Testing, Bioassay, Bacterial Endotoxin Test (BET), Microbial Limit Test (MLT), and Sterility Testing.
- Ensure compliance with regulatory standards for microbiological testing and environmental controls.
3) Quality Assurance (QA) Analytical
Qualification: M.Sc. in Biotechnology or Microbiology
Experience: 3 to 6 years
Key Responsibilities:
- Review Analytical Reports, Stability Protocols, and Data Sheets for accuracy and compliance.
- Investigate and manage Out-of-Specification (OOS), Out-of-Trend (OOT), and other laboratory anomalies.
- Oversee Standard Operating Procedures (SOPs) within the QA department, ensuring adherence to cGMP guidelines.
- Handle laboratory deviations, change controls, and ensure that all processes meet regulatory requirements.
4) Quality Assurance (QA) QMS
Qualification: M.Sc. in Biotechnology or Microbiology
Experience: 6 to 8 years
Key Responsibilities:
- Lead Quality Management System (QMS) activities, including failure investigations, quality event handling, and change control.
- Manage regulatory compliance by handling market complaints, self-inspections, and Annual Product Quality Reviews (APQR).
- Oversee trending of OOS/OOT results and provide guidance on resolving quality issues.
- Collaborate with different departments to ensure all quality processes are aligned with regulatory standards.
Required Qualifications and Skills
- M.Sc. in Biotechnology or Microbiology.
- 3 to 6 years of experience in Quality Control or Quality Assurance.
- Hands-on experience in protein analysis, microbiological testing, bioassays, and environmental monitoring.
- Strong knowledge of cGMP, GLP, and regulatory documentation requirements.
- Excellent analytical skills and the ability to conduct in-depth investigations of laboratory incidents.
Preferred Skills
- Experience working in a biotechnology or pharmaceutical environment is highly preferred.
- Familiarity with regulatory agencies and their documentation requirements.
- Knowledge of advanced laboratory equipment and instrumentation.
How to Apply
Interested candidates who meet the qualifications for the QC or QA roles are encouraged to apply by sending their updated CV along with current and expected CTC to the following email:
- Email: neha.v.patel@zyduslife.com
Application Deadline: 15th September 2024
Please ensure your CV highlights your relevant experience in pharmaceuticals, biotechnology, or related fields, as preference will be given to candidates who meet the specific requirements.
About Quality Control (QC) and Quality Assurance (QA)
In the pharmaceutical industry, Quality Control (QC) is responsible for testing and verifying the quality of products, ensuring that they meet regulatory standards. QC professionals work with advanced techniques such as protein analysis, bioassays, and microbial testing to monitor the safety and efficacy of pharmaceutical products. For more information on Quality Control, visit the Wikipedia page on Quality Control.
On the other hand, Quality Assurance (QA) ensures that all processes and products adhere to the Good Manufacturing Practice (cGMP) guidelines, minimizing risks and ensuring product consistency. QA focuses on maintaining quality throughout the manufacturing process, handling regulatory compliance, and investigating any deviations from standards. To learn more about Quality Assurance, visit the Wikipedia page on Quality Assurance.
Join Zydus Biologics
Zydus Biologics offers an exciting opportunity for professionals in the biotechnology and pharmaceutical sectors to contribute to cutting-edge work in a highly regulated industry. By joining the team at Zydus, you will have the chance to work in an environment that fosters innovation, excellence, and compliance with the highest global standards.
Contact Information:
For additional information or queries, feel free to reach out to the Hiring Manager at Zydus Biologics:
- Email: neha.v.patel@zyduslife.com
Take the next step in your career and be part of a world-class pharmaceutical company committed to improving global healthcare. Apply today!