Quality Control - Analyst (Moraiya)

Role name:  QC (Analyst)

 

·         Division                                   -           Moraiya

·         Department                           -           Quality Control

·         Category                                 -           Staff

·         Qualification                          -           B.Sc./M.Sc./B.Pharma/M.Pharma

·         Experience                              -           3 - 5 Years

     Eligibility                      -         Minimum of 2 years in the same role at any formulation manufacturing site of Zydus in India. (minimum 2 performance rating in the current role)

 

Job Responsibilities:

·         To perform the sampling of raw material and re-test material.

·         To perform Analysis of raw material/packaging material/in-process samples/intermediate/bulk & finished products/ process validation samples/ stability samples/ cleaning validation/method transfer sample etc.

· Preferred to have a Hands-onexperience to perform analysis on HPLC/GC/UV-Visible Spectrophotometer / Dissolution Apparatus etc. 

·         To make entries in SAP and LIMS as per requirement.

·         To maintain the equipment/instrument in operational, calibrated and qualified condition.

·         To handle, store the testing samples as per the respective material/ product requirement.

·         To charge Stability samples as defined in SOP and stability protocols.

·         To handle and dispose the testing samples/rejections after completion of analysis as per SOP.

·         To ensure all primary standards/working standards/certified standards/reference standards are stored as per the storage conditions specified and documented.

·         To ensure laboratory inventory management.

·         To initiate incidence/ OOS/ OOT/ OOC/ Deviation /CAPA /Change control and investigate (if required) under consultation with the department head/section head.

·         To prepare the specification, standard operating procedure, general test procedure and any other applicable document for quality control department.  

·         Responsible for maintaining a neat and systematic work area at all times.

·         Responsible for following Current Good Laboratory Practices (cGLP).

·         Identify and report quality issues.

·         Report accidents and unsafe conditions or unusual circumstances to section in-charge/ head.

·         Other duties, which may be assigned from time to time, by reporting manager.

·    Ensure/check proper cleaning of QC glass wares/tools/apparatus.

 

Essential job requirements:

·         Understands the purpose and function of analytical process and equipment/instrument.

·         Execute procedures for analysis in accordance with standard test procedures (STP), general test procedure (GTP), protocol and related SOPs. 

·         Ability to document in log books, Test data sheets while performing the job using good documentation practices.

·         Attention to detail and ability to write and record data as per ALCOA policy.

·         Comply with the Privilege rights matrix (PRM) of the Organization.