QA(Qualification & validation) Specialist Job

QA (Qualification & Validation) Specialist is needed to perform the following duties:

· Assure cGMP compliance in Qualification and Validation of systems, equipment, utilities, and facilities throughout their lifecycle.

· Ensure a risk-based approach in Qualification and Validation activities.

· Plan and establish Qualification and Validation requirements for projects.

· Establish qualification activities for new or modified systems within the change control process.

· Prepare and approve Validation Master Plans (VMPs) and support project execution across sites.

· Approve qualification and validation protocols, final reports, and periodic review documentation.

· Support internal audits, customer audits, and health authority inspections.

· Control, close, and approve deviations, CAPAs, improvement plans, and change controls related to validation.

· Manage complex projects and analyses with significant business impact.

· Make quality and timely decisions using multiple sources of scientific and operational data.

· Manage risk and uncertainty; anticipate and escalate roadblocks to prevent deviations from objectives.

· Perform duties safely and in compliance with environmental, health, and safety (EHS) regulations.

· Promote continuous improvement and application of LEAN tools to achieve departmental objectives.

· Execute professional activities in compliance with GMP, HSE guidelines, and internal policies (SOPs, COPs, HBRs).

Bachelor's Degree is required in Chemistry or Pharmacy or Pharmaceutical Engineering.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave