Major Responsibilities:

Management of weekly QA batch release planning of Biologic products

Review of batch documentation in preparation of batch certification by QP to ensure compliance with GMP and with the marketing authorizations as well applicable and correct documentation for release (CoA, CoC etc.)

Management (Initiates, investigates and ensures timely closures) of key quality systems including deviations, change controls, CAPAs, complaints associated with the products, by liaising with CMOs, QA Manager/QP , operations, QC and other Sun stakeholders associated with Drug Substance/API , Drug Products or Medical Devices appropriately and in a timely fashion.

Lead and organize periodic quality meetings to evaluate the status and timely

closing of Change Controls, Deviations, and CAPAS with CMOs, internal
departments (QP, Supply Chain and RA), process and product-related.

Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required.

Preparation of annual product reviews (APR/PQR) of Biologics products

Manages and maintains product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release.

Review, prepare batch document for QP Batch release of clinical trial batches, and ensures proper maintenance of product specification files to ensure compliance with INDs and IMPDs.

Responsible for receiving, managing, and tracking CMO change notification; performing timely communication with both internal and external internal stakeholders according to the requirements of Quality Agreements.

Ensures the comprehensive use of risk management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the
marketing authorizations.

Works closely together with the Quality System Manager to support the QA IT systems and acts as a back-up for QA IT systems activities.

Support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures.

Support the maintenance and update of Quality Management System.

Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authorities

Education Qualifications (Graduate- Post Graduate)

Mandatory

HBO or Bachelor Degree in (Bio-)Chemistry, Pharmacy, Biotechnology or similar education.

Minimum of 8 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.

Strong knowledge of EU GMP, US CFRs

Well versed in Microsoft Excel.

Fluent in English

Work experience Mandatory

Tenure: minimum 8 years

Industry: (Bio) pharmaceutical, sterile manufacturing

Content areas: Manufacturing, QA/QC, QA operations.

*Working Place is designated by the company