Fresenius Hiring Regulatory & Engineering

Fresenius Kabi API Jobs | Regulatory & Engineering

Fresenius Kabi Oncology hiring Regulatory Affairs, Engineering and Supply Chain professionals in Kalyani. M.Pharm, Chemistry, Engineering candidates apply.

Experienced pharmaceutical professionals looking for career opportunities in the API manufacturing sector can explore the latest openings announced by Fresenius Kabi Oncology Ltd. The company is actively recruiting qualified candidates for Regulatory Affairs, Engineering Instrumentation, and Supply Chain functions at its API manufacturing facility in Kalyani, West Bengal.

This hiring initiative is aimed at professionals with experience in pharmaceutical regulatory affairs, API sourcing, engineering maintenance, instrumentation systems, vendor management, and cGMP-compliant pharmaceutical operations. Candidates with relevant API industry experience and immediate joining availability will be given preference.

For professionals searching for API pharma jobs, regulatory affairs vacancies, pharmaceutical engineering careers, supply chain jobs in pharma, and pharmaceutical manufacturing opportunities, this recruitment drive offers an excellent opportunity to work with a globally recognized healthcare organization.

Company Overview

Fresenius Kabi Oncology Ltd. is part of the global Fresenius Kabi group, a healthcare company known for developing and manufacturing high-quality pharmaceutical products and healthcare solutions worldwide. The organization operates across multiple therapeutic areas and maintains a strong reputation for quality, innovation, regulatory compliance, and patient-focused healthcare solutions.

The Kalyani facility plays an important role in API manufacturing and pharmaceutical operations, supporting the company’s commitment to delivering safe and effective medicines to global markets. Professionals joining Fresenius Kabi gain exposure to international regulatory standards, advanced manufacturing systems, pharmaceutical quality frameworks, and globally compliant business practices.

The company emphasizes professional development, technical excellence, operational efficiency, and continuous improvement, making it a preferred employer within the pharmaceutical and healthcare industry.

Job Role & Responsibilities

Regulatory Affairs – Officer / Senior Officer

Qualification: Master’s Degree in Pharmacy or Chemistry

Experience: 2+ Years

Key Responsibilities

• Preparation and review of Drug Master Files (DMF).
• Support regulatory submissions for domestic and international markets.
• Manage product lifecycle documentation and regulatory updates.
• Ensure regulatory compliance with applicable guidelines.
• Maintain documentation systems and submission records.
• Support audit readiness activities and regulatory inspections.
• Coordinate with cross-functional teams for compliance requirements.
• Monitor changes in pharmaceutical regulatory requirements.

Engineering Instrumentation – Executive / Senior Executive

Experience: 5+ Years

Key Responsibilities

• Perform calibration of process instruments and equipment.
• Ensure compliance with cGMP and SOP requirements.
• Maintain engineering documentation and maintenance records.
• Manage DCS and PLC-based systems.
• Execute preventive maintenance programs.
• Participate in commissioning and qualification activities.
• Support CapEx projects and engineering upgrades.
• Conduct root cause analysis (RCA) for equipment-related issues.
• Ensure reliable operation of instrumentation systems.

Supply Chain – Executive / Senior Executive

Experience: 5+ Years

Key Responsibilities

• Manage strategic sourcing activities within API manufacturing operations.
• Conduct supplier qualification and vendor management activities.
• Perform vendor risk assessments and supplier evaluations.
• Develop dual sourcing strategies to ensure uninterrupted supply.
• Ensure compliance with cGMP procurement practices.
• Source API, RM (Raw Materials), and KSM (Key Starting Materials).
• Manage packaging material procurement activities.
• Participate in onsite and remote technical audits.
• Support cost optimization initiatives and procurement efficiency programs.

Eligibility / Qualifications

Educational Qualifications

Regulatory Affairs

• M.Pharm
• Master’s Degree in Chemistry
• Equivalent postgraduate qualification in a relevant discipline

Engineering Instrumentation

• B.E.
• B.Tech
• Diploma in Instrumentation, Electrical, Electronics, or relevant engineering discipline

Supply Chain

• Graduate or postgraduate qualification with relevant pharmaceutical supply chain experience
• Preferred exposure to API manufacturing environments

Relevant Courses

M.Pharm, Pharmaceutical Regulatory Affairs, Pharmaceutical Analysis, Industrial Pharmacy, M.Sc Chemistry, Analytical Chemistry, Instrumentation Engineering, Electrical Engineering, Electronics Engineering, Supply Chain Management, Pharmaceutical Management, Operations Management, Procurement Management.

Experience Requirements

• Regulatory Affairs: 2+ Years
• Engineering Instrumentation: 5+ Years
• Supply Chain: 5+ Years

Preferred Candidate Profile

• Experience in API pharmaceutical manufacturing.
• Strong understanding of cGMP and pharmaceutical compliance.
• Good documentation and communication skills.
• Knowledge of regulatory requirements and quality systems.
• Immediate joiners preferred.

Why Join Fresenius Kabi?

Fresenius Kabi offers professionals the opportunity to contribute to a globally recognized healthcare organization with strong quality and compliance standards.

Key Benefits

• Opportunity to work with a global pharmaceutical company.
• Exposure to international regulatory standards.
• Career growth within API manufacturing operations.
• Experience in advanced pharmaceutical engineering systems.
• Participation in strategic sourcing and supply chain initiatives.
• Professional development opportunities.
• Collaborative and quality-driven work culture.
• Exposure to global pharmaceutical business practices.

Professionals seeking long-term careers in pharmaceutical manufacturing, regulatory affairs, engineering, procurement, and supply chain management can benefit significantly from this opportunity.

Location & Salary

Location: Kalyani, West Bengal

Salary: Approx. ₹6 LPA – ₹15 LPA (Based on role, experience, qualifications, and company policies)

Application Process

Interested candidates can apply by sending their updated CV to the official recruitment email.

Email Application

Email: subhajyoti.beura@fresenius-kabi.com

Subject Line Format

Use the following format while sending your application:

FKOL – Department Name – Candidate Name

Example:

FKOL – Engineering – Candidate Name

Important Notes

• API pharma manufacturing experience is preferred.
• Early joiners will receive preference during the selection process.
• Candidates should ensure their resume highlights relevant technical expertise and achievements.

Frequently Asked Questions (FAQs)

1. Which departments are hiring at Fresenius Kabi Oncology Ltd.?

The company is hiring for Regulatory Affairs, Engineering Instrumentation, and Supply Chain departments.

2. What qualification is required for Regulatory Affairs roles?

Candidates must possess an M.Pharm or Master’s Degree in Chemistry.

3. Is API industry experience mandatory?

Yes, candidates with API pharmaceutical manufacturing experience are preferred.

4. What is the job location?

The positions are based at the Kalyani API facility in West Bengal.

5. Are immediate joiners preferred?

Yes, Fresenius Kabi has specifically mentioned that early joiners will be preferred.

6. How can candidates apply?

Candidates can email their updated CV to subhajyoti.beura@fresenius-kabi.com using the prescribed subject line format.

Category	Details
Company	Fresenius Kabi Oncology Ltd.
Department Vacancies	Regulatory Affairs (Officer/Sr. Officer), Engineering Instrumentation (Executive/Sr. Executive), Supply Chain (Executive/Sr. Executive)
Qualification	M.Pharm, M.Sc Chemistry, B.E, B.Tech, Diploma, Relevant Graduate/Postgraduate Qualifications
Experience	2+ Years, 5+ Years
Location	Kalyani, West Bengal