Rygen Biopharma has announced an exciting opportunity for experienced Quality Control (QC) professionals looking to advance their careers in the biotechnology and biopharmaceutical sector. The company is seeking qualified candidates with 3–5 years of experience in Quality Control to support laboratory testing, compliance, and product quality assurance activities.
This opportunity is ideal for candidates with strong expertise in analytical instrumentation, laboratory operations, regulatory compliance, and documentation practices within the biotech industry.
About the Opportunity
Quality Control plays a critical role in ensuring that pharmaceutical and biotechnology products meet stringent quality standards before reaching patients. Rygen Biopharma is looking for detail-oriented professionals capable of performing analytical testing, maintaining laboratory equipment, reviewing results, and ensuring compliance with cGMP and GLP requirements.
The role offers an excellent platform for career growth while contributing to innovations that improve healthcare outcomes.
Key Responsibilities
Selected candidates will be responsible for:
Testing raw materials, in-process samples, and finished products using analytical instruments.
Operating and maintaining laboratory equipment such as HPLC, pH meters, and spectrophotometers.
Performing chemical, physical, and biochemical testing activities.
Reviewing and approving test results, investigations, and deviations.
Ensuring compliance with cGMP, GLP, and regulatory requirements.
Maintaining accurate laboratory records and ensuring data integrity.
Preparing and managing SOPs and STPs in accordance with Good Documentation Practices (GDP).
Supporting method development, method validation, and technology transfer activities.
Collaborating with cross-functional teams for continuous quality improvement initiatives.
Eligibility Criteria
Candidates should possess:
3–5 years of Quality Control experience in the biotech or biopharma industry.
Strong knowledge of analytical testing techniques and laboratory instrumentation.
Hands-on experience with HPLC, pH meters, spectrophotometers, and related equipment.
Good understanding of cGMP, GLP, and regulatory guidelines.
Expertise in SOP and STP preparation and documentation practices.
Strong analytical thinking and problem-solving skills.
Educational qualification such as BSc/MSc in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.
Skills Preferred
Successful applicants are expected to demonstrate:
Laboratory troubleshooting abilities.
Regulatory compliance awareness.
Data analysis and interpretation skills.
Strong documentation and reporting practices.
Attention to detail and commitment to product quality.
Effective communication and teamwork skills.
Benefits Offered
Rygen Biopharma provides:
Career growth opportunities.
Collaborative and innovation-driven work culture.
Health and wellness benefits.
Exposure to advanced analytical technologies.
Opportunities to contribute to life-changing biotechnology products.
How to Apply
Interested candidates can submit their updated resumes to:
Email: dvr@rygenbiopharma.com
Candidates are encouraged to highlight their analytical instrument experience, regulatory knowledge, validation activities, and quality systems expertise in their applications.
Technical FAQ
1. What is the role of HPLC in pharmaceutical Quality Control?
High-Performance Liquid Chromatography (HPLC) is used to separate, identify, and quantify compounds in pharmaceutical samples. It helps determine product purity, assay values, impurity profiles, and stability characteristics according to regulatory standards.
2. What is the difference between cGMP and GLP?
cGMP (Current Good Manufacturing Practices) governs manufacturing processes to ensure product quality and consistency, while GLP (Good Laboratory Practices) focuses on laboratory testing procedures, documentation, and data integrity to ensure reliable test results.
3. Why is method validation important in Quality Control?
Method validation demonstrates that an analytical method consistently produces accurate, precise, specific, robust, and reproducible results. Regulatory agencies require validated methods to ensure the reliability of quality testing data.
4. What is data integrity in a QC laboratory?
Data integrity refers to maintaining complete, accurate, consistent, and trustworthy records throughout the data lifecycle. It follows ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
5. What are SOPs and STPs in pharmaceutical laboratories?
SOPs (Standard Operating Procedures) provide detailed instructions for routine laboratory operations, while STPs (Standard Testing Procedures) describe specific analytical testing methods used to evaluate samples and ensure compliance with quality specifications.
