Cadila Pharma

Major purpose of the job :
•	To maintain best practices for Document Management System
•	To maintain QMS documents and timely, accurately compiled it with all evidence to justify.
Principal task and responsibilities :
1.	Document Management system:  
•	To maintain document cell through proper file numbering and tracking of whole documents for timely retrieval of the document during Audit.
•	To inform all department for periodic review of SOPs monthly basis and prepare master list of SOP six monthly.
•	To maintain each document soft copy of current version of Master. To participate in master Biotech QA sever creation and management.
•	Issuance, Retrieval and Archival of Master documents, logbooks, training and control copies of VLP, Botulinum, BQA and CPLB facilities
•	To issue and maintain training questionnaires of all CPL biotech and CPLB departments.
•	To maintain final scan copy of current MMD, MFC, Protocols, reports and SOPs.
•	To prepare Editable MMDs.
•	To revise Master Equipment list of VLP, Botulinum, BQA and CPLB facilities.  
2.	Handling of QMS documents (Deviation, Incident, change management system, OOS, Market complaints, shutdown, Risk Assessment), Monitoring the improvement timely for on time closure of CAPA and its effectiveness of VLP, Botulinum, BQA and CPLB facilities.  
3.	QA coordinator in TIMS to upload SOPs and training questioners 
4.	Cross function co-ordination for any QA related activities.
5.	To prepare the process validation protocol, Cleaning validation, Hold time study protocol, media fill, execution of the protocols and finally preparation of the reports as per requirement.
6.	Timely prepare Purchase Indent for QA stationary and general requirements of QA and takes Follow ups for same.    
7.	Prepare and communicate GRN to purchase. and maintain details in excel from. 
8.	To prepare daily report, monthly report and additional protocols assigned by immediate superior/HOD from time to time.
9.	Coordinate for Technology Transfer activities 
10.	To prepare Standard Operating Procedures pertaining to QA department.
11.	Review Stability data of Drug Product and Drug Substance and its maintenance in document cell. 
Secondary Responsibility : 

12.	To review SOPs, Quality analysis documents, QMS documents related GCF, EPO, STR, BMN, BQC and IMM department as and when require.
13.	To participate in cross functional activities as defined by HOD QA from time to time.
14.	Any other job assigned by immediate superior/HOD from time to time.

Job Details

Skills Required

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