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NOC Code for Document Control Specialist- Quality Assurance Department- Pharmaceutical Company

jithinraju

Newbie
Feb 23, 2022
1
0
Hi if anyone can help me to find the NOC code for the below Job responsibilities and duties. I searched a lot but I could not find the right code for my qualification. Please it will be great help someone can help me out.

Education: Masters in Pharmacy

Job Duties:
  • Creation and management of item codes for new pharmaceutical material items.
• Review of Artwork, Coordinating with regulatory, production, QC, Planning, and commercial department.
• Ensuring that COA’s for finished products are issued to the sales department (container list) as and when required.
• Ensure the destruction of retention samples after end of the retention period.
• To arrange samples for local second release and archiving MOH release records.
• Collaborates with management and supervisory personal from operations, Quality Control and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and flowing up with Operations for non-conformance issues and a working jointly towards resolutions.
• Provide guidance and plan of action to the manufacturing floor when production events occurs as defined by SOP and lead investigations of non-complaint issues according to procedures as defined by SOP and lead investigations of non-conformance issues according to procedures as defined by SOPs.
• Prepare complaint investigation reports and work closely with others onsite events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommended.
• Implementation of Document control Management as per Good Documentation Practices for Pharmaceutical Industry for Quality control documents and records.
Implement and maintain document control processes, Including.
• Numbering, mastering and issuance
• Review and version Control
• Maintain and manage electronic and hardcopy documents as required.
• Traceability, registering, and distribution.
• Archiving, retrieval and expiration management.
• Day- to day support of the document control workflow in compliance with pharmaceutical GMP Quality Management System.
• Support the coordination, preparation and implementation of controlled documents arising from document change controls CCL’s
• Preparing Quality documentation SOP’s to cover GMP and Good Documentation procedure, as applicable.
• Preparing and maintaining the Master lists of SOP’s and QMS documents.
• Compile and keep up-to-date the physical Quality manual and Site Master File and other QA documents for Audit support.
• Review and edit product documentation for technical content and consistency. Interact with concerned departments and process owners for content compliance with GMP.
• Coordinate with technical department to review, revise, and issue complaint technical and quality documentation.
• Distribute controlled, authorized copies of technical and quality Standard Operating procedures. Ensuring that the current version documents are available at the related areas.
• Assistance in the preparation collation and issue of reports and registers as may be required.
• Issuance and distribution of authorized copies of batch manufacturing and batch packing records for the production department. Archival of these records till there retention period. Recollection of expired copies.
• Review document and testing completion and perform system batch release/rejection for finished product after compliance review.
• Receipt/distribution of sampling checklist for Raw/Packing materials received in warehouse.
• Management of retention sample inventory and related recording (Manual & Electronic) including receipt, appropriate storage, removal and transfer of destruction upon expiry. Ensure accurate traceability, proper storage and handling throughout lifetime and report deviation events.
• Issue retest request as per requirement for retest material for QC labs followed by approval and filling.
• Arrange for SOP’s and COA and other QA document/report requirements for regulatory.
• Review and clearance of samples required for regulatory as per the destination requirement.
• Any work related task assigned by Manager.