plastemartjobs.com

Email: jobs@plastemart.com, hr@plastemart.com

Download Date: 4/2/2025 6:04:21 PM

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RefNo: CA - 36227
Gender: Male
Age: 38

Designation: Manager in QA department 

Highest Education Level: Masters - Degree

Preferred Location: Valsad

Education Details: 
M.Sc.  2012  M.K.U  56.00%



B.Sc  2009   V.N.S.G.U   57.20%





Skill Sets: 
SAP System

Windows 8 &  Window 10.

MS Office & Internet

Work Experience: 15

Work Experience Details: 
Manager in QA department

From - 6th July 2009.

Company profile-  Manufacturer, Supplier & Exporter of Pharmaceuticals containers such as Ampoules, Tabular Vials, Glass Syringes



Job Profile - Looking for all over QA document & maintain them.

Planning for New Machines and Instruments Installation related document.

Making of New SOPs and Revision QA related Documents.

Monitoring Calibration and validation activity.

Reviewing of Non-Viable particle Count Reports, UTM reports & Profile Projector report etc.                                                                                                         

BMR Reviewing & Approval.

Preparation & review of Conformity Certificate related PFS.

Review of In process Quality Assurance report.  

To complies the data and to prepare Annual Product Quality review.

To review issue, distribute, control and retrieval of the Quality documents.



To Review the validation activity and document including validation protocol of equipment (DQ, IQ, OQ, PQ), process, facility, system, validation summary report, risk assessment and do the risk assessment of equipment, system, process etc.

To perform the internal Audit and close out the overall internal audit report with CAPA.

Handling of QMS Document.

Handling of validation activities for HVAC, Water System, Autoclave, Steam sterilizer, ETO , Washing and Siliconization Machine, Depyrogenation Tunnel , Packing Line .

Handling of ISO 9001,ISO 13485 and ISO 15378 related audit and documentation.

Guideline compliance.

MRM ,Self inspection ,Vendor Qualification, Customer Complaint and Customer Audit Handling, 

Experience of Health Canda Audit Handling.

Looking QA Department in absence of QA Head.

Any other responsibilities allotted by Head of dept.







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