Find Quality Jobs in Athlone County Westmeath

Drug Product Manufacturing Associate Alexion
BidvestNoonan —Athlone, County Westmeath
- Full-time
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Supervisor, Pharma labs
Thermo Fisher Scientific —Athlone, County Westmeath
- Overtime
- Presentation skills
- Bachelor's degree
- No degree
Quality Manager
Kepak Group —Athleague, County Roscommon
- Full-time
- No degree
- Referral programme
Quick apply
Senior Group Leader - Cell Lab
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Management
- Presentation skills
- No degree
Director, Quality Management Systems
Teleflex —Athlone, County Westmeath
- Engineering
- Project management
- Bachelor's degree

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Drug Product Manufacturing Associate Alexion

BidvestNoonan -
Athlone, County Westmeath

Quick apply

Job details

Full-time | Fixed term

Qualifications

Microsoft Word
Microsoft Excel
English
Bachelor's degree

Full job description

About The Role

The Drug Product (DP) Manufacturing Associate will be a key member in supporting the execution of operational readiness at the Alexion Athlone Manufacturing Facility. The Manufacturing Associate will be an SME in a number of unit operations throughout the Fill Finish manufacturing process and will be responsible for execution of batch operations as per standard operating procedures under limited supervision.

Responsibilities:

Operate manufacturing equipment and instruments and complete assigned tasks in a timely manner
Execute the production schedule / plan on a day-to-day basis to meet production forecast and the required output
Perform daily / weekly /monthly internal calibrations and verification checks ensure all documentation is complete in a timely manner
Provide Technical support for troubleshooting equipment and process activities
Complete Master Batch Records (MBRs), logbook entries and any required GMP documentation to cGDP
Prepare, review and approve MBRs, SOPs and logbooks
Perform logbook reviews to ensure all documentation is in line with audit readiness
Record and update production metrics
Ensure all training is performed in full and completed in a timely manner
Ensue all tasks performed are compliant with cGMP and EHS guidelines
Work as a team to support, develop and encourage collaboration with all departments to work as one team on site
Ensure all production deviations are raised with Production Supervisor / QA immediately
Support Root Cause Analyse for all quality deviations within the production areas, complete assigned CAPA actions within the designated timeframe
Support the creation of EHS task risk assessments within the production areas
Report any machine issues (Downtime or Rejects) to the Team Supervisor and to the maintenance department
Assume responsibility for the day to day housekeeping duties within the assembly area
Routinely draft/ create and revise standard operating procedures, manufacturing batch records and other documents as required
Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
Embrace Alexion Core Competencies
Aseptic Filling with RABS in grade B background
Compounding / Formulation of products
Sterile Filling of vials / syringes using Isolator
Visual Inspection of finished product.
Cleaning and Sanitation of equipment
Operation of Parts washers and Autoclaves
Troubleshoot and resolve operational problems during processing
Represent Manufacturing in cross functional initiatives and meetings
Perform Manufacturing review and approval of critical documents
Maintain good housekeeping and clean and sanitize classified areas as required

Requirements:

Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
Must be able to read, write and converse in English
Must have good working knowledge of MS Excel and Word
Ability to work in an intense, fast-paced work environment
Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
Ability to work independently and as part of a team
More than 2 years’ experience in a cGMP biopharmaceutical manufacturing environment.
Basic knowledge and understanding of a computer.
Must be willing to work on a 2 shift basis - The company will operate 2 shifts 5 days, Shift will be 7am-3pm and 3pm-11pm
Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant cleanroom regimes
BA/BS in a scientific discipline or equivalent experience preferred

About Us

Bidvest Noonan is a team of 27,000 passionate and customer-focused people. We work together to deliver exceptional service and value to customers across the UK and Ireland. We recruit great people to deliver our services and we provide them with the resources, training, and direction they need to do their best work.

We always put people first. Our people are exceptional and go the extra mile to deliver outstanding services. We celebrate and recognise their successes at every opportunity. At Bidvest Noonan, we strive to make each person feel appreciated, engaged, and supported so that they can reach their potential, knowing it has a positive impact on our overall success.

Bidvest Noonan is highly committed to creating an inclusive environment where everyone can feel valued and respected. We are delighted to welcome applicants from our Armed Forces community and people from diverse backgrounds and identities.

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quality jobs in athlone county westmeath

Drug Product Manufacturing Associate Alexion

Supervisor, Pharma labs

Quality Manager

Senior Group Leader - Cell Lab

Director, Quality Management Systems

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