Tuesday, June 8, 2021

SYMBIOTEC PHARMALAB PVT LTD Urgent Openings for QC QA R and D Production Regulatory Affairs

 SYMBIOTEC PHARMALAB PVT. LTD, 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.


Urgent Vacancy for Chemist/ Officer/ SR. Officer/ Executive-QA/ QC /R&D/ RA/Production at SYMBIOTEC PHARMALAB PVT. LTD, Indore

Job description:

R&D

Position- Research Associate/ Scientist

Experience- 2-6 Years

Qualification-M.Sc (Organic Chemistry)/PHD.

Job Description:

  1. To  manage the analytical  Method development ( HPLC/GC) for In-process control, intermediates and finished products.
  2. To review the verification & calibration of all major analytical instrument in Analytical development Lab.
  3. To assist in analysis at Quality control in initial new products batches of pilot plant those are taken by R&D.
  4. Preparation of  Analytical Documents in TTD formats.
  5. To rectify the trouble shooting problem in analytical area .

R.A.:

  • Position- Officer/ Executive
  • Experience: 2-5  years
  • Education: M.Pharm / M.Sc.

Functional Area:

  1. Compilation and Review of drug muster file for US ,EU and ROW markets
  2. Preparation and review of CEP’s (COS)
  3. Creation of Technical Packages for ROW/ Emerging markets and open part of DMF for customers as per marketing requirements.
  4. Preparation and review of updates, amendments , supplements for the submitted DMF
  5. To respond the customers and agencies quires in timely manner.
  6. To review API specification , STP’s , validations And change controls

Quality Control

  • Position- Chemist/ Officer/ Sr. Officer
  • Experience- 2-6 Years
  • Qualification-BSc/M.Sc

Job Description:

HPLC-

1.To perform and maintain calibration records of HPLC in QC lab.

2.To ensure proper and regular servicing of all the analytical instruments.

3.To ensure updation of all HPLC log books.

4.To initiate and completion of analytical record for HPLC.

5.To carry out HPLC analysis of Raw-materials, finish products, intermediates and working standards.

6.To perform and achieve departmental objectives.

7.To follow the guidelines of GLP and cGMP requirements.

8.To carry out instrumental analysis of stability samples

9.To maintain HPLC columns records.

10.To carry out chemical analysis of raw materials, finish products, intermediates and working standards.

Wet Lab:
1. To carry out the analysis of raw materials, in- process, intermediates, packaging materials, finish
Products, water & working standards.
2. To updation of log books of raw materials, in process, packaging materials and finish products.
3. To updation of log books and preparation of test solution and volumetric solution.
4. To perform sampling of water, raw materials, packaging materials, intermediates and finish products.
5. Temperature monitoring of QC lab.
6. To follow the guidelines of GLP and cGMP requirements.
7. To perform calibration of instruments like pH meter, conductivity meter, Karl – Fischer, Analytical
Balance, LOD oven, vacuum oven.

Quality Assurance (IPQA):

  • Position- Supervisor/ Officer
  • Experience- 2-6 Years
  • Qualification-BSc/M.Sc

Job Description:

  1. To issue correct version of BMR/BPR/PCOCR/MCVR and other documents.
  2. To review filled Batch manufacturing record and analytical record.
  3. Verification of work in progress of manufacturing plant in accordance to approved BMR/BPR and SOP’s.
  4. To verify the equipment/shop floor cleaning and shall check the results of cleaning samples analysis during changeover of product.
  5. To perform dispatch related activity.
  6. To verify packing activities of finished product for dispatch as per OIS & SOP.
  7. To verify line clearance for next product.
  8. To verify the calibration and verification of weighing balance.
  9. To review filled Batch manufacturing record and analytical record.
  10. To prepare the department SOP as and when required.
  11. To exercise document and data control whichever required.
  12. To issue and retrieval controlled copies of logbooks and monthly formats of all department.
  13. To initiate, wherever essential and to handle change control, deviations and incidents, CAPA.
  14. To maintain the storage of master copies of all controlled documents.
  15. To verify dispensing activities of raw material required for production of API.

API Production Sterile:

  • Position- Chemist/Officer/Sr. Officer
    Experience- 2-8 Years
  • Qualification-BSc/M.Sc

Job Description:

  1. Preparation of documents for production.
  2. To co-ordinate with Production people and control manufacturing activities.
  3. To co-ordinate with other departments like maintenance, QC, warehouse and QA etc. for smooth production.
  4. To review production documents and check that are filled adequately and signed.
  5. To ensure that correct raw materials are issued for respective batch.
  6. To check status on materials during all stages of operation.
  7. To co-ordinate in reviewing the non-conformance of the product.
  8. To ensure congenial and safe work environment.
  9. To monitor production activities to meet the products requirements.
  10. To perform and achieve department objectives.

Interested candidates please mail your cvs at hrd@symbiotec.in

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