Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
Post: QA Validation Coordinator
Job Description:
Job Purpose:
To coordinate all the activities of Validations, Qualification, Calibration, Change Controls, documentation of validaiton protocols & deviaitons, maintain the VMS, vendor documents such as validation manuals for plant machinaries, laboraotry equipment, Planning, Organising, Coordinating validation and monitor validation life cycle
Job Dimensions:
The position holder accomplishes his job on his / her own there are no direct reportees.
• The position holder has accountability for the effective and efficient monitoring of the validation schedules, re-validaiton schedules, validation documents archival, controling of validation documents, handling of Validation Management System (VMS), Reterival of validaiton doucments, supporting to audits and provide validaiton documents,
• Develop and monitor data base management system protocol, equipment, drawing numbering
• The position holder is responsible to monitor the site wide ‘validaiton cooridinaiton requirements’, provides VMS, ensuring all internal and external requiremnts are adhred to.
Key Responsibilities:
Operations
• To preapare and monitor the validation and re-validaiton shcedules of process equipments, facilities, utilities and lab equipment and ensure they are maintained in defined frequencies.
• To maintain the documentation like issuance, archival, reterival of validaiton protocols and documentaion of all validation reports and share with all stakeholders
• To monitor the validations activity during installation of plant and machinery at the site. Ensures facility, Process Equipment, Cleaning, Lab equipment & test methods are validated before commercial production
• To monitor the calibration of test and measuring equipment in Quality Assurance, manufacturing and to coordinate with Engineering for overall calibration program at the site as per QMS requirements.
• Develop master calibration schedule for lab equipment and monitor effectiveness of site calibration program
• To monitor the Validation Management System, maintian the protocol data base, equipment number data base in the system, drawing data base, validaiton manual archival and other relevant certificates from vendor.
• To maintain and evulate the effectivenes of vendor perofrmance during execution of validation activities in the site.
• To coordinate required resources to Quality Engineers during execution of validaiton activiites to maintain the validaiton life cycel.
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Candidate Profile:
Key Behavioural Competencies Required: Adaptability, Innovation, Initiative, Teamwork, Integrity
• Decision making skills in order to handle the Validation and related quality problems involved at Site,
• Sense of urgency in planning, coordinating of validation function so as to ensure all Equipment, Process and Methods are validated on time
• Communication skill in order to understand and provide necessary feedback to customers.
• Interpersonal skill in order to develop healthy relationship between the key customers production and engineering team members
Education: Graduate or Post Graduate from Science Background
Additional Information:
Location: Gujarat-Jhagadia
Education: B.Sc, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 25th April, 2013
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