Senior Manager Validation

JOB DESCRIPTION:

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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations QualityDIVISION:EPD Established PharmaLOCATION:Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, LandhiADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:NoMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)