BE / BSC / B PHARM / DIPLOMA
Experience: 12 Years +( Entire career in Tablet Mfg and currently Handling High volume of Tablet Manufacturing) Should be working in company having USFDA/MHRA/TGA...
Can review protocol and report of qualification and validation activities.Review of SOP.Deliver Training.To perform invstigation of failure.Review of Batch records.Review of QMS records. Review of IPQA activities on shop floor.Conduct self inspection...
- Handling complete in-process quality control and continuous improvement in process capabilities, managing quality across raw materials, work in progress, finished goods in various functional departments as per the standards
- Formulating standard ...
*having Competency in Qa / Qc Knowledge in the Field of Us Fda, Cgmp, Mhra Orange Guide and Glp Guidelines. Having a Strong Background On Regulatory Guidelines for Equipment Qualification (dq, Iq, Oq, Pq), Cleaning Validation, Process Validation (pr...
 Candidate should be in Formulation plant in Pharma company and also having exposure of USFDA MHRA audit.
 Having hands on experience of HPLC and GC.
 Candidate should be in Quality control Department.
a. Good Communication Skills.
b. Experience must be from API / Bulk Drug Industry.
c. Should have thorough knowledge on Change management, Deviations, Market complaints, Recall and OOS investigations.
d. Exposure to USFDA , EDQM, MHRA, TGA Audits....
Key Skills : qa chemist,qa executive,qa consultant,qa lead
Experience in Injectable is Mandatory
minimum Experience Require is 12 to 15 Years
qualification Require is B.pharm , M.pharm , M.sc. / Ph.d
having Expertise in Evaluation & Implementation of Cgmp , Routine Site Quality Assurance Activity...