Job Description
Position Manager-Quality Control
Educational Qualification(Required) M. Sc / B. Pharma / M. Pharma
Experience(Required) 8-15 yrs
Technical Skills & Knowledge
Handel instrument such as HPLC, GC, UV, Conductivity
Analysis of FG, RM, PM, Chemical,
Handel SAP
Key Responsibilities
- To drive Quality Policy and encourage continual
- Improvement in quality system at site to meet regulatory and customer requirements
- To Ensure GLP, GxP and CSV compliance and audit trail review in laboratory instruments/equipment
- To review and investigate by finding out root cause for OOS/ OOT/ Incident / Laboratory errors impacting Quality analytical results and closure within time as per frequency of SOP
- To plan, supervise and review analytical testing and releasing of RM/PM/BULK/FG on time as per urgency
- To establish Quality Measurement System and keep the top management informed
- To ensure instrumental, chemical and microbiology test report raw data review and approval on time Monitoring of In QLI/ AQL
- Approval of Standard Operating Procedure and Specifications, Standard Test Method, Method of analysis and other quality documents
- To review Annual product quality review Review and approval of Quality Assurance / Quality control documents and records
- To ensure timely calibration, review and approval of instrument/equipment calibration as per SOP
- To ensure process validation of each and every new product
- Approval and Execution of Validation Master Plan
- To review and ensure periodic Trend Analysis of Purified Water and Environment monitoring
- To ensure periodic Training Program on GMP and GLP
- To ensure the Job Description and Training Matrix of all Quality personnel is prepared as per current Job profile and each individual performing the particular task is trained
- Monitoring of Environmental Controls
- Ensure Validation of Mfg. / Filling Equipments by swab and rinse water
- To ensure investigation has been performed for any failure and CAPA
- Responsible for the approval of stability study protocol , stability study as per protocol, stability charging , stability sample retrieval and analysis, stability report review , evaluation of stability data and handling of stability chamber
- To Review and approval of Site Master File
- To ensure that every instrument/equipment used in Quality is calibrated as per frequency of the SOP, review of the calibration records and related communication with the vendor/third party
- To communicate and justify to management the resource requirement to implement the quality management system to meet regulatory and customer requirements
- To strive for the continual improvement in Quality by conducting internal audits and review
- To prepare and execute the technical agreement between contract giver (VVF) and contract acceptor (Party) is signed and agreed by both
- Ensuring proper and systematic functioning of Quality System to meet regulatory and customer requirements Ensure review of Batch Mfg. Records prior to release
- To give training to Quality personnel of SOPs and related to OOS, OOT, Laboratory error, Deviation to avoid reoccurrence
- To monitor and ensure that the Quality productivity is as per organization requirement
- To timely short out any type troubleshooting on instrument /equipment and other occurring in Quality
- To monitor , supervise and handle the team knowing their competency for the best productivity and least error in Quality
- To take and complete any other responsibility as given by reporting Head and above management on time to time as per requirement