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CAREERS

  • Job Posted On 19/08/2016

Designation : Manager, QC

No of Positions : 1

Edu. Qualification : M. Pharm, M.Sc.

Experience : 15 And Above Years

Work Location : Gummidipoondi, Injectable plant

Requirements : M. Pharm, M.Sc. having 15+ years of experience with sterile / formulation unit,having experience and strong exposure in regulated markets and skill in facing / handling regulated audits.

Responsibility :

1.Monitoring and Executing of the routine activities.

2.Planning for routine analysis of in process, Finished Products, Raw Material Finished, Packaging Materials, and Stability Samples with respective intervals.

3.Review and approvals of the Quality control analytical documents, Stability samples, Raw material Packaging material samples of Critical care testing division.

4.Trouble shooting of analytical related problems.

5.Responsible for the maintenance of cGLP in QC laboratories.

6.Responsible for ensuring correctness of Quality control Analytical the documents as the sample testing and approvals.

7.Responsible for the maintenance of all the Instrument logs, Usage logs as the part of testing samples. 

8.Responsible to ensure all necessary testing is carried out systematically and correctly.

9.Responsible for the maintenance of HPLC/ GC Columns and with respective performances Records.

10.Review of Quality control SOP’s as per periodic revision schedule

11.Monitoring of Online Documentations (manual). 

12.Qualification of Quality Control Instruments, Stability Studies, and Vendor Qualification,Quality Management Systems,  like Change control, Deviation, CAPA, Market complaints, Product failures, regulatory audit and compliance.

13.Co ordination with Regulatory Affairs department for handling of various registration data for their effective implementations.

14.Technology transfer/receiving of analytical methods as per regulatory requirements,

15.Review and approval of SOP training matrix for Quality control.

16.Planning and ensuring the SOP training as per the SOP Matrix as well as new joined persons SOP training and Analyst training activities.

17.Development & implementation, monitoring & continually improvement of QMS as per regulatory requirement.

18.Selection and development of teams for various activities like, analysis, validation, monitoring & audits.

19.Stability study of different Pharmaceuticals dosage forms as per ICH guidelines,

20.Quality check & handling of Internal & external audit. Review& approval of qualifications documents of QC instruments.

21.Trouble shooting, Calibration & Maintenance of different laboratory Instruments/Equipment.

22.Management of Reference standards, working standards and impurities used for analysis.

23.Effectively utilized the resources and analytical instruments as a part of analysis of all stages of material to products.

24.Investigation of OOS and OOT generated in the quality control department.

Generic QC experience and successful track record in injectable/Formulationare highly preferred. Sustained relief technology injectable manufacturingQC, Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.


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