Posted Mar 31, 2017 29 views
Job Summary:
Provides support to Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related with Products, Processes, Equipment, Utilities, Facilities, Test Methods, Cleaning and Laboratory Instruments. To prepare and implement Validation Master Plan and other Validation strategies aimed at achieving the efficient use of resources and supporting the business growth in Pakistan.
Principal Duties:
· Implementation and compliance of all the SOPs and EPO/AQR Policies and Procedures related with Validation/Qualification.
· Preparation of Validation Master Plan (VMP), its implementation and updating at least annually.
· Validation and Qualification activities related with Products, Processes, Equipment’s, Utilities, Facilities, Test Methods, Cleaning and Laboratory Instruments.
· Approval and filing of Validation documentation (Validation Change Request, Design Qualification, Protocols, Reports etc).
· Ensuring appropriate training of VRB and Validation execution Team and keeping the records.
· Validation/Qualification studies other than the routine schedule like Plant Expansion Projects and Continuous Improvement Projects, new products, stability.
· Sending Validation Metrics to EPO on quarterly basis.
· Provide validation support for supplier approval (whenever required).
· Preparation, approval and filing of Product Quality Review (PQR) of Top sales/Export Products.
· Preparation of QA Checklist for Request for Capital Expenditures (RCEs), Quality and Regulatory Issues and Action Plans (whenever required).
· Representing affiliate in Regional Validation Business Council Meetings.
· Provide Validation support to other sections of QA i.e. QA Documentation, QA System and Compliance, CAPA, PTC, Supplier Approval, Stability, TPM etc.
· Provide support in terms of Process Validation in the launch of new products.
Job Details
Abbott Laboratories Pakistan Ltd
About Abbott At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Abbott in Pakistan In Pakistan, Abbott employs almost 1,500 people across 6 locations. Abbott has 2 manufacturing facilities located in Landhi and Korangi in Karachi, in addition to commercial and support functions. Abbott serves the Pakistani market with a diverse range of health care products including branded generic pharmaceutical, nutritional, diagnostic and diabetes care products and solutions. Abbott has been operating in Pakistan since 1948.
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