QA Development Associate at Novartis

Job Description

• Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
• Ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions, archive relative documentations.
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant GMP regulatory and legislative requirements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with GMP/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.
• Establish a good working relationship with the Supply Chain Management (SCM), RA and Medical departments.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, distributors) and Global Quality Assurance.
• 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. Support / participate in NEM cases as required.

Minimum Requirements

• Operations Management and Execution.
• Collaborating across boundaries.
• Functional Breadth.
• Bachelors in Pharmacy, Sciences or related fields.