Requirements: English
Company: SUN PHARMA
Region: Hoofddorp , North Holland
About the role
This position is responsible for ensuring support for compliance in Sun Pharmas products manufactured externally, worldwide. This includes management support of product development and commercial quality operations, in addition to ensure on-time release of product under release responsibility of Quality group plus appropriate maintenance of local quality systems. He/she ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement and Regulatory expectations. Supports the QMS that consolidates Health Authority Regulations into Sun Quality requirements for products.
Major Responsibilities
- Management/Support of weekly QA batch release planning of products
- Review of batch documentation for batch certification ensuring compliance with GMP and with the Marketing Authorizations as well applicable and correct documentation for release (CoA, CoC etc.)
- Management/Support (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, Primary QP, operations, QC and other Sun stakeholders associated with Drug Substance/API , Drug Products or Medical Devices appropriately and in a timely fashion.
- Management/Support periodic quality meetings to evaluate the status and timely closing of Change Controls, Deviations, and CAPAS with CMOs, internal departments (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
- Supports 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 certification of clinical trial batches, and ensures proper maintenance of product specification files to ensure compliance with INDs and IMPDs.
- Responsibility 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 regulagory authorities
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate)
Mandatory
- HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy or similar.
- Minimum of 5 years of relevant experience in 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 5 years
- Industry: Pharmaceutical, sterile manufacturing
- Content areas: Manufacturing, Regulatory, QA/QC. QA operation.
Technical Competencies
- Experience on preparation of batch release, including batch documentation review and preparation for batch certification.
- Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)
- Good understanding and experience in API/DP pharmaceutical operations, QA/QC processes and contract manufacturing.
- Good understanding of complex change control processes and interaction with regulatory affair processes.
- Good understanding of regulatory submission processes.
- Capable of reviewing and assessing manufacturing and analytical technical documents and provide sound quality assessments on change controls, deviations and complaints.
- Experience working with elec