QA Specialist (12 month fixed term contract)

Job title:

QA Specialist (12 month fixed term contract)

Company:

Alexion Pharmaceuticals

Job description

Job DescriptionPosition SummaryThe QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF will be responsible for providing oversight of quality activities associated with the manufacture and disposition of bulk drug substances at ADMF. The QA Specialist is responsible for ensuring that manufacturing, testing, labelling, and storage of Bulk Drug Substances comply with all applicable GMP regulations and the product authorizations’. 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. This position is a shift position, operating in extended days (7am-7pm, 4 days on, 4 days off).Principal Responsibilities

  • Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.
  • Review and approval of executed batch records in accordance with Alexion’s internal procedures and GMP principles.
  • Review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
  • Review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.
  • Review and approval of 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.
  • 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 Supplier Management Program.
  • Complete review and releasing raw materials and components as required to support manufacturing operations.
  • Develop and report quality metrics.

Qualifications

  • English fluency written and spoken (the Company language).
  • Strong verbal and written communication skills with well-structured communication and presentation ability.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Minimum 3 years in pharmaceutical and/or biotech industry.
  • Strong mature leadership and interpersonal influencing skills.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.

Education

  • Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Dublin

Job date

Fri, 18 Apr 2025 22:59:48 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.

yonnetim

Published by
yonnetim
Tags: academic

Recent Posts

Alternance Business Analyst Développement Clinique & Pharmacovigilance (H / F)

Job title: Alternance Business Analyst Développement Clinique & Pharmacovigilance (H / F) Company: Servier Job…

4 minutes ago

Senior Solution Architect Foundation: Front-End Platform

Job title: Senior Solution Architect Foundation: Front-End Platform Company: Rabobank Job description Job Title Senior…

5 minutes ago

Support Worker

Job title: Support Worker Company: St. Christopher's Services Job description St Christophers Services CLGSt. Christopher's…

18 minutes ago

Senior Machine Learning Scientist (UK Remote)

Job title: Senior Machine Learning Scientist (UK Remote) Company: Turnitin Job description Company DescriptionWhen you…

23 minutes ago

C/C++ Software Engineering Technical Leader – Network Platform Forwarding

Job title: C/C++ Software Engineering Technical Leader - Network Platform Forwarding Company: Cisco Systems Job…

25 minutes ago

Vedligeholdstekniker med håndværker kompetencer – Danmark Protein

Job title: Vedligeholdstekniker med håndværker kompetencer - Danmark Protein Company: Arla Foods Job description Location:…

26 minutes ago
If you dont see Apply Button. Please use Non-Amp Version