10/01 Gurpreet Kaur
HR Manager at Sphaera Pharma Pvt Ltd

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Sphaera Pharma - Quality Control Chemist (2-6 yrs)

Haryana/Manesar Job Code: 8809

Position: Quality Control Chemist

Location: IMT Manesar, Gurugram, Haryana

Education Qualification: Bachelor of Science/ Master of Science/ B. Pharma / M. Pharma

Technical Qualification: Approved by FDA (Analytical Section)

Work Experience: Minimum 2 years of experience in Quality Control

Soft skills: Good verbal and written skills, positive attitude, ability to work well with others, strong initiative, and willing to accept additional responsibilities, Ability to work with moderate supervision, strong attention to details. Must be have computer skills.

General Responsibilities:

- Knowledge of cGMP & cGLP, ISO 13485 & 21 CFR.

- Perform analytical tests in the laboratory & maintain smooth laboratory work flow.

- Obtain lab certifications and complete QA/QC assignments.

- Operation and Cleaning of Equipment used in the Quality Control Department.

- On line monitoring of the environment conditions in process area.

- Trouble shooting of the equipment during process.

- Preparation of SOP, STP, GTP & Specifications, Calibration & verification of equipment.

- Maintaining the daily logs of the process area. Environmental Monitoring in premises.

- Approve batches, incoming raw materials, packaging materials and routine analysis of the different samples.

- Maintain all analytical equipment according to the schedule & SOP.

- Review and Update test methods and procedures according to SOP. Carry out process control, including in-process checks/inspection/line clearance.

- Prepare reports of Calibration of equipment/ RM/ PM/ Bulk/ FG samples, document findings and recommendations.

- Coordinate with personnel in other disciplines to integrate findings and recommendations.

- Strong interpersonal, writing, and multi-tasking skills with the ability to work in a team.

- Documentation capabilities like filling of BMR / BPR, CAPA, Stability Studies Report, IPQA Documents/Activities in different departments such as Production, Store, etc.

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