

Kairose Pharma Pvt Ltd.
2-5 Years
25,000 - 45,000 /Monthly
Ahmedabad, Gujarat, India
Key Responsibilities: Oversee and execute comprehensive quality assurance activities for injectables and sterile products manufactured at Kairose Pharma Pvt Ltd.'s Ahmedabad facility, ensuring strict adherence to cGMP regulations and international quality standards. Manage and meticulously review critical quality documentation, including batch production records, Standard Operating Procedures (SOPs), and quality system documents, vital for maintaining product integrity and regulatory compliance within our pharmaceutical manufacturing environment. Actively participate in the investigation of deviations, non-conformances, and out-of-specification (OOS) results, identifying root causes and implementing effective Corrective and Preventive Actions (CAPAs) to enhance process robustness for sterile manufacturing operations. Conduct thorough in-process and final product quality checks, focusing on critical parameters for sterile formulations and injectables, to uphold the high-quality reputation of Kairose Pharma's offerings and ensure patient safety. Support and facilitate internal and external audits (e.g., regulatory inspections from Indian and international bodies) related to quality systems, ensuring all necessary documentation and procedures are rigorously maintained for our 101-250 employee pharmaceutical company. Contribute proactively to continuous improvement initiatives within the Quality department, leveraging expertise in pharmaceutical industrial operations to optimize quality control processes for sterile injectable products. Essential Requirements: Bachelor's or Master's degree in Pharmacy, Pharmaceutical Science, Microbiology, or a closely related scientific discipline from a recognized institution. Minimum 2 years and maximum 5 years of experience required. Proven technical expertise in Quality Assurance or Quality Control specifically within the Pharmaceutical industry, with a strong focus on manufacturing environments for Injectables & Sterile Products. In-depth knowledge of cGMP, GLP, and pertinent regulatory guidelines (e.g., ICH, USFDA, MHRA, PICS) essential for sterile pharmaceutical manufacturing operations in India, especially relevant for a growing company like Kairose Pharma in Ahmedabad, Gujarat. Demonstrated ability to meticulously handle quality documentation, manage change controls, deviations, and CAPA systems effectively. Excellent analytical, problem-solving, and communication skills to collaborate effectively across departments within a mid-sized pharmaceutical company (101-250 employees).
Applicants: 144
Vacancies: 2
Job Title/Designation:
Senior Quality Executive
Job Responsibilities:
Key Responsibilities:
Essential Requirements:
Key Responsibilities:
Essential Requirements:
Work Shift:
General
Health, Safety and Physical Demand Requirements:
na
Risks Associated:
na
Sub-Industries:
Department:
Quality
Job Type:
Full-time
Work Type:
On-Site
Preferred Industries:
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Job Location
Bhayala, Gujarat, India
About Company:
Company overview is not available yet.
Industry:
Pharmaceutical
Company Type:
MNC
Company Size:
Company (101-250 employees)
Website:
Sub-Industries: