Job Information
Abbott Senior Manager Validation in Karachi, Pakistan
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, Cleaning validation, computer system validation of lab and SLP of lab. 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.
Ensure preparation and keeping up to date the site Validation Master Plan and ensures that the validation Master is following Abbott policy.
Manage timely performance of qualification activity of all production and utilities equipment’s according to validation master plan and timely preparation and approval of qualification Protocol and Report according to Validation Master Plan.
Ensuring appropriate training of VRB and Validation Execution Team and keeping the records.
Ensure preparation of cleaning validation program, SOPs, Protocol and Reports.
Review test method validation plan, SOPs, protocol, and reports.
Review laboratory validation SOPs, protocol, and reports.
Represent validation status to higher management via monthly and quarterly management review meeting.
Preparation of QA checklist for request for Capital Expenditures (RCEs), Quality and Regulatory Issue and Action Plan (whenever required).
Representing affiliate in Regional Validation Business Council Meetings.
Provide Validation support to other sections of QAI i.e., QA Documentation, QA system and
compliance, CAPA, KTC Supplier Approval, Stability, TPM etc.
Provide support in terms of Process Validation in the launch of new products.
Validation/Qualification studies other than the routine schedule like plant Expansion projects and continuous improvement projects, new products, stability. Abbott - Established Pharmaceuticals Division
Provide Validation support for supplier approval (whenever required).
Comply and ensure compliance to Health, safety and Environment Polices, guidelines and requirements as applicable by law and Abbott Guidelines.
Develop team to better accomplish and perform in their duties as quality professionals.
Review lab equipment against SLP requirement.
Any other responsibility assigned by Director QA.
Knowledge & Experience:
Knowledge regarding Validation of Process, Equipment, and Facility etc. most preferably in Multinational Pharmaceutical.
8-10 years of experience in relevant filed.
Minimum Qualifications:
- Minimum requirements: B. Pharm / PharmD / Master of Science
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com