Fresenius Kabi Oncology Limited is inviting applications for multiple pharma career opportunities at its Kalyani, West Bengal API manufacturing facility. The openings cover Engineering, Regulatory Affairs, Production Engineering, Quality Assurance and Quality Control, with experience requirements ranging from 2+ to 7+ years.
The Kalyani facility manufactures oncological and non-oncological APIs and operates under international quality and GMP standards.
The vacancies are particularly relevant for experienced professionals looking for Fresenius Kabi jobs in West Bengal, API pharmaceutical manufacturing jobs, regulatory affairs jobs, pharma QA/QC jobs and pharmaceutical engineering careers.
Fresenius Kabi Kalyani Jobs – Quick Overview
| Particular | Details |
|---|---|
| Company | Fresenius Kabi Oncology Limited |
| Industry | API Pharmaceutical Manufacturing |
| Location | Kalyani, West Bengal, near Kolkata |
| Positions | Utility Engineer, Regulatory Affairs Officer/Sr. Officer, Production Engineer, QA Compliance/Data Integrity, QC Analyst |
| Experience | 2+ to 7+ years depending on position |
| Job Type | Experienced Pharma/Engineering Positions |
| Application | Updated CV via email |
| Work Location | Kalyani API manufacturing facility |
Fresenius Kabi Oncology’s official careers information confirms that the company recruits professionals for its pharmaceutical operations and provides a career application facility.
1. Engineering – Utility Engineer
Experience: 5+ Years
The Utility Engineer role is suitable for professionals experienced in pharmaceutical utility and engineering maintenance.
Key Responsibilities
- Manage utility maintenance and engineering maintenance activities.
- Support boiler operations and maintenance.
- Handle and monitor chillers and compressed-air systems.
- Implement preventive and breakdown maintenance programs.
- Ensure pharmaceutical engineering systems comply with GMP requirements.
- Support energy-management initiatives.
- Coordinate facilities-management activities.
- Manage engineering vendors and service providers.
- Support CAPA and investigation activities.
- Maintain EHS and regulatory compliance.
- Contribute to energy-management systems such as ISO 50001.
Suitable Qualifications
The supplied vacancy does not specify the educational qualification. Relevant backgrounds would typically include B.E./B.Tech in Mechanical, Electrical or related Engineering disciplines, subject to the employer’s actual requirements.
2. Regulatory Affairs – Officer / Senior Officer
Experience: 2+ Years
Business Area: API Regulatory Affairs
This opening is focused on regulatory activities associated with API products and international submissions.
Key Responsibilities
- Prepare and maintain regulatory documentation.
- Support DMF preparation and maintenance.
- Coordinate regulatory submissions.
- Work on eCTD and dossier documentation.
- Support product lifecycle management.
- Coordinate post-approval changes.
- Prepare CMC-related regulatory documents.
- Support global registration activities.
- Maintain regulatory compliance.
- Assist with audit and inspection readiness.
- Coordinate with cross-functional teams for regulatory requirements.
Suitable Qualifications
Potentially relevant qualifications include M.Pharm, B.Pharm, Pharmaceutical Sciences, Chemistry or related disciplines, depending on the company’s detailed job criteria.
3. Production Engineer – Chemical Engineering
Experience: 3+ Years
The Production Engineer position is aimed at professionals with experience in API manufacturing and chemical production operations.
Key Responsibilities
- Manage API manufacturing and batch-processing activities.
- Monitor production processes and parameters.
- Ensure compliance with approved SOPs.
- Maintain BMR and production documentation.
- Follow cGMP requirements throughout manufacturing.
- Ensure EHS requirements are followed.
- Handle production deviations and related documentation.
- Support CAPA and quality-system activities.
- Coordinate shift operations.
- Identify opportunities for process improvement.
- Maintain production records and manufacturing documentation.
Suitable Qualification
B.E./B.Tech in Chemical Engineering would be the most relevant educational background for this role.
4. Quality Assurance – Compliance / Data Integrity
Experience: 7+ Years
This is a senior-level QA compliance and data-integrity opportunity within pharmaceutical manufacturing.
Key Responsibilities
- Review laboratory and computerized-system data.
- Perform audit-trail reviews.
- Support data-integrity compliance.
- Manage deviations, CAPA and change controls.
- Support QMS activities.
- Ensure GxP and cGMP compliance.
- Apply ALCOA+ data-integrity principles.
- Support DIRA activities.
- Work with systems such as Empower, Tiamo, LIMS and TrackWise.
- Support laboratory and QC compliance.
- Assist with regulatory inspection and audit readiness.
- Ensure compliance with applicable regulatory requirements, including 21 CFR expectations.
Suitable Qualifications
Relevant educational backgrounds may include B.Pharm, M.Pharm, M.Sc. Chemistry/Life Sciences or related pharmaceutical disciplines, combined with substantial QA/data-integrity experience.
5. Quality Control – Analyst
Experience: 5+ Years
The QC Analyst position is suitable for professionals with strong analytical laboratory experience in pharmaceutical quality control.
Key Responsibilities
- Perform pharmaceutical analytical testing.
- Operate and troubleshoot HPLC and GC systems.
- Conduct chromatographic analysis.
- Review analytical results and laboratory documentation.
- Follow cGMP and GDP requirements.
- Maintain data-integrity standards.
- Support laboratory investigations where required.
- Maintain QC documentation and records.
- Ensure testing activities follow approved procedures.
Suitable Qualifications
Likely relevant qualifications include B.Pharm, M.Pharm, M.Sc. Chemistry or related analytical/laboratory disciplines, subject to the employer’s final eligibility criteria.
Why Consider Fresenius Kabi Careers?
Fresenius Kabi describes its career environment as offering opportunities across healthcare, manufacturing, quality, engineering and other functions. The company also highlights professional development, training and international collaboration.
For professionals in pharmaceutical manufacturing, the Kalyani API facility offers exposure to regulated manufacturing operations, quality systems and international GMP requirements. The company’s Kalyani facility is described as a modern API production site with stringent quality, safety and GMP standards.
Potential Career Benefits
- Opportunity to work with a global healthcare organization.
- Exposure to API pharmaceutical manufacturing.
- Experience with GMP and regulated operations.
- Cross-functional exposure across production, engineering and quality.
- Professional development opportunities.
- Experience with international regulatory and quality requirements.
- Potential long-term career growth in the pharmaceutical industry.
Benefits, compensation and employment conditions may vary by position and should be confirmed with the employer.
How to Apply for Fresenius Kabi Kalyani Jobs
Interested and eligible candidates can submit their updated CV/resume to:
Email: subhajyoti.beura@fresenius-kabi.com