Job description

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:

Role: QA Specialist (Batch Release)

Reports to: Quality Team Leader

Job Purpose

We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit and batch release team.

The QA Specialist will be responsible for the following.

· Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP).

· These activities include, supporting batch release activities, document review,Data Integrity activities, change control, non-conformance investigations, compliance auditing, and other related quality system elements.

· You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.

What you’re great at:

· Excellent interpersonal skills

· Ability to operate as part of a team is critical.

· Customer focus

· Innovative

· Excellent communication skills both written and verbal

· Attention to detail

· Good problem solving skills

· Results and performance driven

· Adaptable and flexible

· Integrity, trustworthiness and objectivity

· Knowledgeable of FDA/EMEA regulatory requirements

· Ability to build relationships with Operations and other stakeholders

As a QA Specialist, your typical day may include:

· Supports GMP activities from operational through to batch release acticities.

· Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.

· Responsible for implementation of improvements and procedures for the management of change control and deviation management.

· Quality oversight of project activities including but not limited to,improvements within the batch release team, data integrity and system improvements.

· Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.

· Key participant within the QA team in the execution of their duties.

· Executes the activities of the group within quality to create a synergistic approach to goals and tasks.

· Irregular Domestic and international travel may be required

Be vital:

· Bachelor’s Degree in a scientific/technical discipline required

· A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.

· Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

· Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

· Focus on patients and customers at all times.

Desirable:

· Advanced degree (MS, MBA, PhD) preferred

· Experience in Quality Assurance team

· Experience in direct interactions with regulatory agencies during site inspections.

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: On the road

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