Job Summary: The QC In charge is responsible for overseeing all quality control
activities related to the inspection, testing, and release of components and assemblies
used in biopharma fluid handling systems. This includes pumps, valves, tubing, hoses,
and cleanroom assemblies. The role ensures adherence to internal quality standards,
industry regulations (e.g., GMP, ISO 13485), and customer specifications, while
maintaining documentation to support compliance and traceability.
Key Responsibilities:
a. Overall responsibility for QA system implementation.
b. Approve SOPs, specifications, and documents.
c. Ensure product release after review of batch records.
d. Review deviations, change controls, investigations, customer complaints.
e. Approve training programs and qualification activities.
f. Ensure compliance with cGMP and internal audits.
g. Liaise with regulatory agencies and management.
h. Ensure the quality system meets ISO 9001:2015 standard.
Qualifications & Experience:
- Bachelor’s Degree or BSc. - Microbiology. BE/B.Tech - Biotech/Chemistry or a related field.
- 5–6 years of QC experience in biopharma equipment, medical devices, or precision
- component manufacturing.
- Strong understanding of cleanroom compliance, bioprocess equipment standards, and
- quality documentation.
Key Skills:
- Proficiency in reading technical drawings, specifications, and MOC documentation.
- Familiarity with QC tools, gauges, and equipment (e.g., vernier calipers, surface testers, pressure gauges).
- Knowledge of ISO 13485, ASME BPE, GMP, and validation practices.
- Strong leadership, communication, and decision-making skills.
- Experience with ERP and digital quality systems is preferred.
Benefits:
- Commuter assistance
- Health insurance
- Provident Fund
Application Question(s):
- what is your current CTC?
- what is your Expected CTC?
- What is your Notice Period?
- How many years of Experience?
Work Location: In person
