Job Description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

• Analyze quality standards for components, materials or services.
• Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

Followings will be the responsibilities of the position holder:

1.0 Environment Monitoring by Active and Passive air sampling of aseptic area of HMXL block, Controlled area of Haemaccel and Microbiology laboratory.

2.0 Surface and Personnel Monitoring of aseptic area of Haemaccel.

3.0 Environment Monitoring by Active and Passive air sampling of ODF area.

4.0 Transportation of all required items from Microbiology laboratory to sampling site and vice versa.

5.0 Preparation of environment isolates for identification.

6.0 Sampling and analysis of In-process samples form production area of Haemaccel.

7.0 Sampling and analysis of WFI, PSC and Purified water from production area of Haemaccel and OSD block.

8.0 Operation and Calibration of Total Organic Carbon analyzer and testing of water samples for TOC content.

9.0 To perform sampling, MLT and bioburden testing of Raw material, Finished product & In process samples.

10.0 Culture handling, sub culturing, seed lot preparation and culture suspension of standard organisms.

11.0 To perform media preparation, sterilization and qualification of media.

12.0 Preparation of Environmental isolates for identification.

13.0 To perform Sterility and Bacterial Endotoxin testing of Finished Goods and stability samples.

14.0 Review of documents in Microbiology lab. All relevant documentation of the activities.

15.0 Investigation of OOS related to Microbiology along with Cross Functional Team.

16.0 Handling of Documentation and change control related to QC Microbiology.

QUALIFICATIONS

• Education - Associates Degree (\xc2\xb1 13 years)
• Experience - Minimum 1 year

The salary for this role is between: N/A

JOB FAMILY: Operations Quality

DIVISION: EPD Established Pharma

LOCATION: India
Village Mauza : Baddi

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott