31 Jul
|
BioSystems Diagnostics Private
|
India
31 Jul
BioSystems Diagnostics Private
India
BioSystems Diagnostics Private Limited (BDPL) has been distributing high-quality in-vitro diagnostic (IVD) products across India since 2003 through a strong and committed network of distributor partners.Established in 2003, BDPL began its journey with trading of IVD reagents and instruments and has since expanded into in-house manufacturing operations in India.
Job Summary:
Responsible for manufacturing, formulation, and packaging of diagnostic/medical reagents while ensuring compliance with quality standards such as GMP, ISO, and regulatory guidelines.
Key Responsibilities:
- Perform preparation and formulation of reagents, buffers, and solutions as per standard operating procedures (SOPs)
- Handle raw materials weighing, mixing, filtration, and filling processes
- Maintain batch manufacturing records (BMR) and production logs accurately
- Ensure adherence to Positive Manufacturing Practices (GMP) and safety protocols
- Operate and maintain production equipment (mixers, reactors, filtration units, filling machines)
- Assist in process validation and scale-up activities
- Coordinate with Quality Control (QC) and Quality Assurance (QA) teams
- Identify and report deviations, and assist in root cause analysis (RCA)
- Ensure proper labeling, packaging, and storage of finished products
- Maintaining the QMS documentation
Required Skills:
- Basic knowledge of biochemical and chemical reagent preparation
- Familiarity with GMP, GLP, ISO standards (ISO 13485 preferred)
- Good documentation and record-keeping skills
- Ability to follow SOPs strictly
- Attention to detail and quality awareness
- Basic knowledge of laboratory instruments and production equipment
Preferred Skills:
- Experience in IVD (In Vitro Diagnostic) reagent manufacturing
- Knowledge of sterile handling / aseptic techniques
- Familiarity with regulatory requirements (CE, FDA guidelines)
- ERP or batch tracking system experience
Pay: ₹30,000.00 - ₹35,000.00 per month
Work Location: In person
📌 Executive Production (Reagents Manufacturing) (India)
🏢 BioSystems Diagnostics Private
📍 India