Job Opportunity

Job Opportunity

QA Senior Release Specialist

QA Senior Release Specialist

Ireland Posted 2023-12-15

QA Senior Release Specialist

As QA Senior Release Specialist, you will have responsibility to ensure the timely and efficient release of biological drug substance batches, including preparation and review of batch disposition documentation to support Qualified Person (QP) confirmation and release.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Department Description

As QA Senior Release Specialist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.

In this role you’ll be reporting to the QA Technical Quality Lead.

Your Responsibilities

In this role, you will carry out essential duties.

Work within the QA DS Release team to ensure timely and efficient release of biological drug substance batches.
Review batch production records, including liaising with QPs, other QA teams, other departments and/or Clients, such as Manufacturing Operations, to resolve any discrepancies noted during the review.
Compile deviations, change controls, QC data and batch production record reports to support batch disposition.
Provide environmental and utilities monitoring data, as required, to QPs to support batch disposition activities.
Provide Annual Product Quality Review(s) (APQRs) and stability data to QPs to support batch disposition activities.
Monitor progress of quality related deviations, corrective and preventative actions, and related documents to ensure batch release timelines are met.
Collate batch disposition metrics and KPIs to monitor batch disposition process performance.
Identify continuous improvement opportunities to ensure batch disposition processes are efficient and remain in a constant state of compliance.
Prepare and review SOPs relating to QA Release activities, as required.
Participate in cross-functional teams and projects, as required.
May be required to provide support QPs, including ensuring that registers are maintained up-to-date and checking that tasks as required in section 1.7 of Annex 16 “Certification by a Qualified Person and Batch Release” are being conducted by the company as per SOPs.
May have a limited number of direct reports, if required.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Technical Quality Lead
Act as a role model for the Quality Assurance function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Qualifications:

A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering).

Experience:

3-5 years’ experience in the biotechnology and/or pharmaceutical industry within a Quality role, preferably in Operations support or similar.
The preferences are for candidates from QA roles but candidates from QC, Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered but demonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required.
Experience in a batch release function would be an advantage

Behavioral/Technical Competencies Required:

Strong planning and communication skills
Awareness of trouble shooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc.
Knowledge of cGxP requirements and regulations
Working knowledge of MS Excel and PowerPoint, e.g. preparation and collation of metrics and graphs
Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
Demonstrated collaboration, negotiation & conflict resolution skills with a teamwork mindset.
Excellent communication skills (written and oral).
Able to challenge the status quo with a continuous improvement mindset.

Onerous Requirements

There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required

Delegation of Responsibilities

When absent from the site duties and responsibilities will be delegated to the following designates:

Job Title: Technical Quality Lead
Job Title: QA Release Specialist

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie/ or contact us via talentacquisition@wuxibiologics.com

WuXi Biologics is an equal opportunities employer.

Apply now