BDS Manufacturing Specialist

This is what you will do:

The Manufacturing Support Team provides manufacturing support to complex life changing biological products. The team supports investigations, changes, improvement projects, operational excellence and documentation.  The team provide a key interface between the shift operations teams and day-based cross functional support. 

The Manufacturing Specialist Investigator responsibilities include the ownership of Upstream and Downstream unit operations investigations and CAPA’s on any process or equipment issues in line with business strategies and objectives.

You will be responsible for:

• Lead, author and co-ordination of Good Manufacturing Practice deviations through the quality management system. This will involve leading structured problem solving of deviations and the identification and implementation of robust CAPA’s.
• Actively monitor and trend investigation and error topics to ensure appropriate and proactive improvements are implemented.
• Support routine day to day compliance for the BDS facility.
• Participate in inspection readiness projects and support internal audits and health authority inspections.
• Take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
• Raise, own and participate in change controls and improvement projects while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
• Update GMP documents (batch records, SOP’s, Work Instructions etc.) as required.

You will need to have:

• A minimum of 5 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
• Good knowledge of GMP/HPRA/FDA regulatory requirements.
• Strong technical writing skills.
• Self-starter with strong communication, problem-solving and presentation skills.
• Ability to work effectively in the cross-functional environment as well as independently on a consistent basis.
• Work collaboratively in a matrix environment.
• Proven ability to work well as part of a team and on own with minimum supervision.

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.