Sr. Executive / Assistant Manager - QC (Medical Devices - Dialyzer)

Role & responsibilities:

1. Monitoring, Measurement, Analysis and Evaluation:

• Monitoring routine and non-routine analyses of raw materials, environmental samples, finished product sample, IPQC samples & stability samples.
• Verify, processes are conforming to established quality standards and required specifications.
• Complete documentation needed to support testing procedures including data, equipment logbooks.
• Monitoring of all equipments, softwares and microbiology department.

2. Control of Nonconforming Product:

• Identifying non-conforming process outputs, semi-finished products and finished product, and taking adequate steps to ensure that it is not delivered.
• Monitoring all the process parameters from store to dispatch level.

3. New Product Development :

• Develop instrument methods for products in pipline.
• Method validation, product validation for R&D products.

4. Documents and Processes for manufacture products that are safe and effective:

• Update several quality specifications, quality formats and SOP as per product upgradation.
• Prepared Protocols for qualifications of HPLC, Analytical Balance & Rotating Bottle Apparatus.

5. Focusing on Training Needs:

• ISO, CE, MRD, GMP, GLP training.
• QC and micro related trainings.

Preferred candidate profile :

• Sound knowledge of QC instruments like HPLC, GC, Stability Chamber & Dissolution Apparatus, UV etc.
• Proficient in various validations of Quality Control instruments, Method and Process.
• Expertise in new molecule method development and in-vitro testing.