1 Opening(s)
3.0 Year(s) To 8.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements.
Key Responsibilities
1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...
4 Opening(s)
2.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
Candidate must have experience from Pharmaceutical Industry and should be ready for traveling for site work across Gujarat and India also.
Execute CSV activities as per GAMP 5, 21 CFR Part 11, and EU Annex 11
Prepare and execute validation deliverables:
Validation Plan / VMP sections
URS, FS, DS
Risk Assessments (FMEA / Risk-based)
IQ, OQ, ...
1 Opening(s)
2.0 Year(s) To 5.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
Performing Bacterial Endotoxin Tests (BET): Utilizing the Limulus Amebocyte Lysate (LAL) assay, specifically the kinetic turbidimetric or kinetic chromogenic methods, to detect and quantify endotoxins in raw materials, in-process samples, and finished products.
Operating Kinetic Readers and Software: Operating specialized microplate readers (e.g., Lonza's Nebula readers or Associates of Cape ...
1 Opening(s)
1.0 Year(s) To 4.0 Year(s)
Not Disclosed by Recruiter
The job description is as below:
To perform High Performance Liquid Chromatography analysis for various pharmaceutical tests including Related Substances, in compliance with 21 CFR Part 11 and cGMP guidelines. The role includes calibration, troubleshooting, integration, and data review activities related to HPLC.
Key Responsibilities:
Perform routine and non-routine HPLC analysis for Assay, Related Substances, Content Uniformity, and other quality ...
1 Opening(s)
20.0 Year(s) To 30.0 Year(s)
Not Disclosed by Recruiter
Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets
To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing.
Key Responsibilities
Quality Systems & Compliance
Implement, ...
1 Opening(s)
7.0 Year(s) To 12.0 Year(s)
10.00 LPA TO 12.00 LPA
Role Purpose:Customer focus - Delivering products well within customer’s expectations on delivery, service, communicationsetcSafety- Building a safer work environment through People centric actionsQuality- Relevant Product quality acceptable to the customer without any defectsDelivery- Delivering on committed timelines to the customer. Deliver in terms of overall improvements inoperations (OTIF)Cost- Developing and ...