Assistant Validation Manager — GMP Compliance & Validation Lead

Abbott Laboratories; Karachi Division; On-site; PKR 900,000 - 1,300,000; Full time

Job summary

Abbott Laboratories in Karachi seeks a Validation/QA specialist to support VRB and Validation Execution Team in Validation and Qualification activities across products, processes, equipment, utilities, and facilities.

The role covers SOPs, protocol development, risk assessments, analytical testing (TOC/HPLC), CAPA, and regulatory audits as part of cGMP compliance. 4–5 years of pharma validation experience is preferred.

Qualifications

• Science graduate or master’s degree; MSc Chemistry, Microbiology or Pharm D preferred.
• 4–5 years’ experience in validation/qualification in pharma.
• Knowledge of validation of process, equipment, utility and facility, preferably in a multinational pharmaceutical setting.
• Proficient in MS Office.
• Strong analytical skills.

Responsibilities

• Implement and ensure compliance with SOPs and EQD/AQR policies for validation/qualification.
• Develop, review, and execute Cleaning Validation Protocols (IQ/OQ/PQ).
• Establish acceptance criteria for product residues, detergents, and microbial contamination.
• Perform risk assessments for cleaning processes and equipment.
• Coordinate sampling and ensure analytical testing (TOC, HPLC, swab/rinse).
• Prepare and review cleaning validation reports and CVMP updates.
• Support qualification of equipment, utilities, CIP/SIP systems.
• Investigate deviations and CAPA implementation.
• Collaborate with operations, QA, QC for continuous improvements.
• Assist regulatory audits as Validation SME.
• Prepare validation deliverables and system lifecycle docs.
• Ensure 21 CFR Part 11 and Annex 11 compliance assessments for electronic systems.
• Coordinate with IT and vendors during implementations.

Skills

Validation/Qualification

Analytical testing

Risk assessment

TOC/HPLC

Documentation

cGMP compliance

Training

Education

MSc Chemistry

M.S. Microbiology

Pharm D

Tools

MS Office

Job description

Abbott Laboratories in Karachi seeks a Validation/QA specialist to support VRB and Validation Execution Team in Validation and Qualification activities across products, processes, equipment, utilities, and facilities.

The role covers SOPs, protocol development, risk assessments, analytical testing (TOC/HPLC), CAPA, and regulatory audits as part of cGMP compliance. 4–5 years of pharma validation experience is preferred.