QA Compliance Specialist

Required Skills

1-3 years of experienceBachelor degree of pharmacy or ScienceGood communications skills.High accuracy level to guarantee the reliability of results.Fluent in English language (reading, speaking and writing).

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. General1.1. 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. 2. 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