Raw Materials AnalystApply Now Email Me Job ID SR0030779 Date posted 02/06/2019 Location:Dunboyne, Ireland
This role will support the Quality Control functional testing on incoming raw materials at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Takeda Dunboyne Biologics, the leading global biotech company focussed on rare diseases. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.
- Conducts testing on raw materials samples.
- Liaises with contract testing laboratories as required
- Organises sample management between laboratories
- Reviewing analytical data, analytical reports and performing peer reviews.
- Performing analytical method transfers and compendial verifications.
- Instrument qualification, maintenance and troubleshooting.
- Protocol generation– method verification/transfer.
- Ensuring good communication with other teams.
- Facilitates material availability for use on site.
- Providing training for team members.
- Following all relevant Standard Operating procedures.
- Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
- Calibrates or verifies calibration of instruments/devices prior to use.
- Complies with all pertinent regulatory agency requirements.
- Execution and on time completion of required training activities.
- Conducts thorough data review to ensure completeness and accuracy of records.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Participates in Laboratory Investigations as required.
- Writes and revises control test procedures and SOPs as required.
- May interact with outside customers or functional peer groups.
- Promotes and exhibits Takeda Values.
- Executing company policies.
- Ensuring self inspections are performed.
- Assist in optimizing test procedures to improve efficiency whenever possible
- Support in establishing and controlling of raw material’s supplier qualification program
- Ensures new/revised quality system requirements are deployed to the Site.
Education and Experience Requirements
- A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, etc).
- Previous GMP laboratory experience in the biotechnology or pharmaceutical industry.
- Excellent communication skills (written and oral).
- An understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Required to work on his/her own initiative in addition to working as part of a team.
- Excellent time management & organisational skills.
- An understanding in analytical methodology (HPLC, GC, Karl Fisher, general wet chemistry and compendial assays).
- Experience in performing analysis of USP, JP and EP pharmacopeia methods
- A working understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
- Previous experience with LIMS/ Empower and/ or Lab-X systems
Key Skills, Abilities, and Competencies
- Excellent trouble shooting and problem solving skills.
- Ability to challenge the status quo with a continuous improvement mindset.
- Promoting a culture where diversity and inclusion is part of the DNA.
Complexity and Problem Solving
- Identifying and communicating risks in area of responsibility and across the site.
- Creating strategies and plans to manage risk within the Quality Contol operation.
Internal and External Contacts
- For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
- For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality Assurance group to support quality excellence.
- For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
- For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Takeda and through external forums to drive business excellence in Quality Assurance.
Other Job Requirements
- There may be a requirement to travel<10% time.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.