Chemist/Officer/Executive, QC/QA/Biotech
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- 2 to 7 Yrs
- Multinational, Abroad
- 5 years ago
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Job Description
Job Summary
As the only fully, Vertically Integrated manufacturer of Steroid-Hormone APIs in India, we offer the unique proposition of providing Steroid-Hormone API Solutions with regulatory support matching 'Western Standards' with 'Asian Cost Advantage'.
The company has successfully completed the construction of its II phase of expansion in i.e. Fermentation Facility and construction of it Chemical Synthesis Facility and production is started.
Chemical Synthesis Facility at Special Economic Zone (SEZ), Pithampur is made to start backward integration of some of its important raw materials like Hydrocortisone Acetate and Betamethasone Base which can be used as intermediate product as well can be sold in the market.
The facility at SEZ , Pithampur is an ultra-modern cGMP compliant Steroids plants with production facilities ranging from a kilo scale to several ton capacity with single batch size exceeding 500 kg for several APIs with dedicated R&D and well equipped Quality Control Laboratory.
Responsibilities and Duties
1.API Production:
Position- Chemist/ Officer/ Sr. Officer/Executive
Experience- 2-8 Years
Qualification- B.Sc/ M.Sc/B.E./ B.Tech
Job Description:
1. To perform and control the manufacturing activities in shift.
2. To maintain batch manufacturing records for the batch manufactured and check that all the BMRs are adequately filled.
3. To maintain all related documents for production.
4. To co-ordinate with engineering and maintenance department for routine activities.
5. To co-ordinate for the raw materials from stores.
6. To perform in safe work environment.
7. To allocate manpower for shift activities.
8. To monitor and maintain good housekeeping in respective areas.
9. To perform and achieve department objectives.
2.Quality Control:
Designation- Chemist/ Officer/ Sr. Officer
Qual- Bsc/ Bpharm/ Msc/ Mpharm
Experience- 1-5 Years
Instruments Handled- GC
Job Responsibility :
1. To maintain calibration records of Gas chromatography in QC lab.
2. To perform GC calibration and maintain record.
3. To initiate and completion of analytical record for Gas chromatography.
4. To carry out the GC analysis of raw materials, finish products and intermediates as required.
5. To perform and achieve departmental objectives.
6. To follow the guidelines of GLP and cGMP requirements.
7. To carry out instrumental analysis of stability samples.
8. To maintain GC columns records
3.Inoculum (Biotech):
Designation- Jr. Executive
Experience- 1-5 Years
Qual- M.sc (Micro/ Biotechnology)
Job Responsibility:
1. To follow the SOPs of Inoculum lab and maintain the training record.
2. To monitor the lab equipments and record their status.
3. To perform verification and calibration of lab instruments.
4. To prepare the batch media and fill the batch manufacturing record.
5. To prepare culture media and sterility media.
6. To perform the sterility test.
7. To perform and record isolation and propagation and maintenance of microbial culture
8. To perform the productivity test.
9. To follow the production planning.
10. To coordinate with QA department for issuance and submission of lab records and for calibration and validation of lab equipments.
11. To coordinate with QC and Micro department for analysis, microbial monitoring and GPT of media.
12. To coordinate with ware house department for issuance of batch media.
13. To coordinate with maintenance department for calibration and validation of lab equipments.
14. To follow the GMP and GDP procedures in Inoculum lab.
4.R & D:
Designation-Jr. Executive/Executive
Qual- MSC
Experience- 1-5 Years
1. To follow the SOPs of R&D lab and maintain the training record
2. To monitor the lab equipments and record their status
3. To follow the SOPs in the lab respectively
4. To execute the R&D experiments given by senior
5. To prepare and control the SOPs and STPs
6. To perform the sterility test and maintain its record
7. To perform daily routine sample analysis
8. To review and update monthly records
9. To assign the work of helpers and workers
10. To train the junior staff and workers
11. To coordinate with suppliers for R&D instruments regarding maintenance
12. To perform the calibration of instruments like pH meter, weighing balance, HPLC, UPLC, etc.
13. To coordinate with QA department for issuance and submission of lab records and for calibration and validation of lab instruments
14. To follow the GMP and GDP procedures in R&D lab
5. IPQA
Designation-Chemist/ Officer
Qual- Bsc/ Bpharm/ Msc/ Mpharm
Experience- 1-5 Years
Job Responsibility:
1. To issue correct version of BMR/BPR/PCOCR/MCVR and other documents.
2. To review filled Batch manufacturing record and analytical record.
3. To prepare the department SOP as and when required.
4. To maintain the records for FP/Intermediate batch release documents.
5. To prepare and review of the APQR.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Hospital Management / Director
Functional Area: Not Applicable
Role/Responsibilies: Chemist/Officer/Executive, QC/QA/Biotech
Contact Details:
Company Name: Electrobrain ModernLocation(s): Multiple Countries, Intl
Keyskills: continuous improvement facilitation
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