QA Specialist, BDS (12 month fixed-term contract) at Alexion Pharmaceuticals

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances at ADMF. He/she is responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs.
The QA Specialist executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

You will be responsible for:

  • Provide quality and cGMP input and oversight for all manufacturing activities for the BDS facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation).
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics.

You will need to have:
  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering)
  • Minimum 3 years in international pharmaceutical and/or biotech industry with increased level of responsibility
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • Ability to operate efficiently in a complex matrix organization and international environment
  • Strong mature leadership and interpersonal influencing skills
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • English fluency written and spoken (the Company language).

We would prefer for you to have:
  • Demonstrated success records in auditing and improvement processes
  • Efficient in SAP, EMDS, MES and Trackwise.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click .

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