QA Specialist

Description

• Ensure imported products comply with the Pharmaceutical Affairs Act and product approval specifications before shipment release.
• Collaborate effectively with internal and external stakeholders to minimize impact and risk during quality-related escalations, deviations, change controls, and complaints.
• Set up and validate processes for new product launches, regulatory updates, and implementation of new testing methods
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
• Ensure that an effective Change Control process is in place.
• Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.

Qualifications

• Must possess a valid pharmacist license (required for registration as an import manager to perform shipment release duties).
• At least 2 years experience at a pharmaceutical manufacturer or importer.
• At least 1 year of direct or close collaboration experience with regional or global teams.
• Business proficiency in English
• Proven ability to align teams around shared goals, foster inclusivity, and inspire team members.
• Demonstrated strength in proactively and constructively resolving issues through cross-functional collaboration.