QA Compliance Specialist

Supports day to day site Quality Compliance needs on the shop floor. Identifies and resolves Quality Compliance issues within the Process Unit unilaterally and cross-functionally. Works closely with the Process Units and Quality Organization to ensure compliance with local regulations through operational oversight, internal audits. Assists with Regulatory Agency inspections/ activities, as needed.

1. General

1.1. Responsible for ensuring compliance with local regulations & ISO Standards. 1.2. Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices and Standard Operating Procedures. 1.3. Ensures that all activities in his/her unit or section are done according the relevant cGMP and ISO standards. 1.4. Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level. 1.5. Actively participates in process improvement teams/initiatives.

1. Specific:

2.1. Participate in external audits relevant activities as per management of corrective and preventive actions procedure. 2.2. Participate in all Change Control activities; reviews and follow up

1-3 years of experience

Bachelor degree of pharmacy or Science

Good communications skills.

High accuracy level to guarantee the reliability of results.

Fluent in English language (reading, speaking and writing).