1. Responsible for performing Environmental monitoring of manufacturing areas and Microbiology lab.
2. To perform plate reading of Environmental monitoring plates, water analysis plates, growth promotion testing and other microbiological analysis.
3. Responsible for autoclave activity.
4. Responsible for Microbial limit tests.
5. To follow and implement best microbiology laboratory practices.
6. Responsible for testing of Sterility, BET and LBPC sample analysis in the microbiology laboratory.
7. Responsible for calibration of Microbiology lab equipment and trend preparation.
8. Responsible for Culture maintenance and seed lot preparation.
9. To follow current good manufacturing practices.
10. To raise the CCF, Incidents and preparation SOP, Protocols.
11. Monitoring of Incubator temperature.
12. Maintain laboratory and equipment cleanliness.
Sr. QC Executive - 5 Positions
1. To perform Sterility test, Bacterial endotoxin test and Particulate matter test of finished product, Raw material and in process samples.
2. To monitor regular activities in microbiology laboratory.
3. To supervise the activities in the microbiology lab and work allocation to the microbiologists.
4. To follow and implementation Microbiological best laboratory practices.
5. Training of personnel and evaluation training given.
6. Verification of all Microbiological analytical documents
7. To participate in the media fill simulation.
8. To maintain good documentation practices.
9. To prepare and execute method validation protocols and equipment qualification protocols.
10. To follow and implementation of laboratory safety.
11. Compliance with cGMP norms
12. Preparation of SOPs.
Asst. QC Manager - 1 Position
1 Follow Good Documentation practices.
2 Responsible for all GLP related Activities
3 To follow all the relevant SOPs pertaining to manufacturing practices.
4 Review of all analytical data and calibration data.
5 Testing of raw materials, packaging materials, finished products and stability samples against test procedures as per the job allocation.
6 Responsible for calibration of all the instruments and review of External agency calibration reports.
7 Reporting of analytical test results to the Head-QC for approval and inform deviations / Discrepancies / abnormal observation / out of specification results and follow the instructions by the Head-QC (If any).
8 Responsible for preparation of Stability data compilation.
9 Responsible for Analysis of Process Validation samples.
10 Monitoring of area and General cleanliness of Laboratory.
11 Responsible for analysis of method transfer and vendor qualifications
12 Initiation of Change controls and Deviations.
13 Investigation of Incidents and OOS.
14 In absence of employee; designee shall expedite the job in consultation with the reporting Authority.
Desired Candidate Profile
Candidate should have good academic background.
Candidate should have good communication skills with command on English writing and speaking.
Candidate should have a valid passport and willing to relocate Russia.