Job description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Description:

QA Technical Support Packaging

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Mgr or Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Key Responsibilities

• Accountable for Quality oversight processes and procedures related to Packaging Technology Transfer/NPI, Validation and Engineering.

• Quality review and approval of Transfer, Validation and qualification documentation and SOPs to support site validation activities:

o Review of DS & QRAES documents

o Review of validation Plans, Protocols, IOQ, PQ and associated validation documents

o Review of executed validation documents and reports

• Quality Review and approval of MBRs and BOMs.

• Perform all activities in compliance with *** safety standards and SOPs.

• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Requirements

Preferred Qualifications

• University degree. Science or Engineering related discipline preferred.

• Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction for NPI/ technology transfer / packaging projects.

• Knowledge of devices/combination products regulations

• Ability to work independently and remotely with minimum direct supervision.

• Critical thinking skills.

• Strong organisational, communication, coordination, and meeting facilitation skills.

• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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Job Type: Full-time

Salary: €21,000.00-€45,855.21 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Dublin, County Dublin: reliably commute or plan to relocate before starting work (required)

Education:

• Advanced/Higher Certificate (preferred)

Experience:

• Customer Support: 1 year (preferred)

Reference ID: 32075

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