Celgene Specialist QA Cpmpliance, Boudry in Boudry, Switzerland
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
PURPOSE AND SCOPE OF POSITION:
This position is responsible for the review of drug substance and drug product related batch records by ensuring accurate and timely maintenance of manufacturing batch records and release documentation received from CSPs used to manufacture, package and test Celgene commercial biological products - in accordance with Celgene policies, standards, procedures and international cGMP’s. The incumbent is required to act as SME for individual areas of expertise in the batch review process and expected to be a reliable source of information and interpretation of quality and cGMP requirements.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Solid knowledge of cGMP in the pharma/Biotech industry as well as EU and FDA regulatory requirements, ICH guidelines.
Good knowledge of biologics manufacturing processes and testing. Knowledge of proteins / monoclonal antibodies manufacturing processes and testing a plus.
Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes and lyophilization a plus.
Thorough knowledge of master batch record concept and executed batch record review process; good understanding of associated foundations (regulatory filings) and core quality processes – e.g. change control, deviations/OOS, CAPA management, product complaints, APR-PQR.
Good understanding of batch disposition principles, EU QP concept and associated duties including liaison with Health Authorities.
Excellent investigational skills and QA problem solving skills – e.g.
Able to routinely recognize Quality issues and articulate process science based solutions.
Capable of providing QA support and guidance to product investigation owners per Celgene procedures requirements and GMP requirements.
Able to perform product investigations.
Able to critically review reports while effectively inputting and expressing Quality risk management principles.
Analytical mindset – e.g.
Able to critically review batch documentation / investigations, and generate technical comments or conclusions.
Able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and accuracy.
Intermediate to advanced ability to interpret results and situations.
Understands the basics of continuous improvement; ability to support implementation of improvement measures in an efficient and timely manner.
Confident in making decisions for minor issues; capable of escalating/ consulting with management for complex issues, capable of proposing solutions as appropriate.
Ability to complete routine tasks with little or no supervision; requires moderate direction to complete more complex tasks.
Ability to work with interdisciplinary teams and partners worldwide, including multicultural working environment. Capable of providing input within the department and cross functional teams with brevity and clarity.
Skilled in planning and organizing, building relationships; action-oriented and customer-focused. Team spirit.
Ability to pay attention to details.
Good knowledge of most common office software (Microsoft Office).
Good verbal and written communication skills in English a must; good command of one Swiss national language a plus.
EDUCATION AND EXPERIENCE (As Applicable):
BS degree, professional diploma in Life Science, or equivalent degree in a relevant discipline, or experience.
Minimum 4 years of experience in a pharmaceutical/ biopharmaceutical environment, including previous QA experience.
DUTIES AND RESPONSIBILITIES:
The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
Review of master documents – e.g. master batch records, bill of materials, specifications, artworks – for assigned products and vendors, ensuring all changes to the process are captured per proper change control practices.
Batch review for assigned products and vendors:
Collection of DS / DP executed batch records along with batch testing documentation and release documentation per release schedule.
Compilation and review of documentation set in a timely manner per procedure methodology.
Participates to the meetings to facilitate timely batches review and release; update the group on the status of documentation review and pending items holding release.
Liaison with vendor for comments solving and documentation correction; schedules / participates to periodic meetings with vendor as appropriate to follow up on open points.
Assessment of all events impacting the batch; liaison with deviations owners for closure.
Assessment of the batch against product specifications and product registration information for approved markets.
Generation of review documentation and preparation of batch disposition file to the attention of batch disposition functions.
Support to batch disposition functions/QPs as appropriate. Archiving of resulting release documentation as required. Execution of lot status change in the electronic system as required.
Tracking and trending of the batch review process, CSP batch review data.
Support to core quality processes – e.g.
Generation and archiving of necessary documentation for CSP batch review qualification.
Support to Change Control management process by reviewing newly created records – e.g. process change, specification change, labeling changes, new product launches - and completing assigned action items in a timely manner.
Completion of deviations / CAPA assigned action items in a timely manner.
Author necessary quality system documents; review and update procedures for Celgene Quality Management System per process ownerships.
Provides timely support and necessary information to QA colleagues, VQMs and Quality Management as required.
Provide timely quality support to Celgene stakeholders and SMEs per project plans for regulatory submissions, new product launches and alternate CMOs related topics for functional area relevant topics.
Acts as representation for Quality Operations and Compliance Management as required.
Support Health Authority inspections and audits of the site, act as QA representative (SME) for functional area relevant topics.
Participate as QA representative to internal work streams, projects and improvement initiatives as needed.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE