QA CMO Biologics Specialist

SUN PHARMA; Hoofddorp; Presencial; EUR 60.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

25 holidays

1 extra day off on your birthday

Descripción de la vacante

A multinational pharmaceutical company is looking for a QA Specialist Biologics in Hoofddorp, Netherlands. The role involves ensuring compliance for Biologic products, overseeing quality assurance activities, and conducting inspections. Candidates should possess a Bachelor's degree in Chemistry, Pharmacy, or related field and 5 years of experience in (bio) pharmaceuticals. Strong knowledge of EU GMP regulations and excellent communication skills are essential. The company offers an international work environment, 25 holidays, plus an extra day off on your birthday.

Formación

• 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
• Advanced knowledge and experience in API/DP biopharmaceutical operations, QA/QC processes and contract manufacturing.
• Good understanding of complex change control processes and regulatory submission processes.

Responsabilidades

• Manage QA batch release planning of Biologic products.
• Review batch documentation for compliance with GMP.
• Support the maintenance of the Quality Management System.

Conocimientos

Strong knowledge of EU GMP

Excellent communication skills

Strong interpersonal skills

Problem-solving abilities

Experience with electronic Document Management

Well versed in Microsoft Excel

Educación

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

Herramientas

Microsoft Office

Trackwise

Descripción del empleo

SUN Pharma is seeking a dynamic QA Specialist Biologics. As the QA Specialist Biologics, the selected candidate will play a pivotal role in ensuring the batch release and certification of our products for commercial use in Europe. Taking the helm of the Pharma Branded team, they will foster a culture of excellence in quality management. Additionally, the selected candidate will be responsible for overseeing the quality assurance and compliance activities of Investigational Medicinal Products (IMPs) for European clinical trials.

Overall Job Purpose

The QA Specialist Biologics is responsible for ensuring compliance in Sun Pharma’s Biological products manufactured externally, worldwide. This includes supporting the Sr. QP/QA CMO Manager Biologics on product development and commercial operations, in addition to ensure on-time release of product under release responsibility of Biological 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 Biologic products

Major Responsibilities

• Management of weekly QA batch release planning of Biologic products
• Review of batch documentation of Biologics and APIs as 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.
• Prepare of annual product reviews (APR/PQR) of Biologics products
• Manage and maintain 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.
• 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)

Qualifications, Knowledge, Experience & Skills

Education Qualifications (Graduate- Post Graduate)

Mandatory

• HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
• 5 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.

Mandatory

• Tenure: minimum 5 years
• Industry: (Bio) pharmaceutical, sterile manufacturing
• Content areas: Manufacturing, QA /QC, QA manufacturing operation.
• 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)
• Advanced knowledge and experience in API/DP biopharmaceutical 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 electronic Document Management, electronic Training systems and Trackwise
• Understanding of risk assessment and risk management fundamentals/tools
• Experience interacting with external parties.
• Good knowledge of MS office and Windows based computer applications.

Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)

• Strong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skills
• Ability to effectively manage multiple, complex priorities and quick shifting of those.
• Team player, task oriented and keen on working in a cross-cultural working environment.
• People oriented with tendency to help others and go beyond her/his area of responsibility.

What we offer

• International environment
• 25 holidays + 1 extra day off on your birthday