Process Support Specialist (IPT)

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.

Overview:

Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with the client s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT

Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP s, SWI s, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.

Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.

Raise CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why s etc.; implement subsequent corrective action through the change management system.

Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.

Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Work collaboratively to drive a safe and compliant culture in Carlow.

May be required to perform other duties as assigned.

Assist in the management and/or assignment of IPT training if required

Requirements

Experience, Knowledge and Skills:

Technical:

SAP knowledge and experience required

Proficiency in Microsoft Office and job related computer applications required

Knowledge of regulatory/code requirements to Irish, European and

International Codes, Standards and Practices

Report, standards, policy writing skills required

Equipment and process validation

Sterile filling processes and equipment

Lean Six Sigma Methodology experience desired

Business:

Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner

Understand the specific responsibilities of all Carlow departments as they relate to one s own

department, understanding the business processes ones department supports

Strong team skills, including ability to coach/develop work teams

Excellent training, facilitation and assessment skills

Risk management skills

Strategy planning and development

Demonstrable analytical and systematic problem solving skills

Strong influencing skills

Flexible approach

Effective time management and multi-tasking skills

Proven organizational skills

Excellent attention to detail

Trouble shooting skills

Goal/results orientated

Leadership:

Focus on Customers and Patients

Collaborate

Act with Candor and Courage

Make Rapid, Disciplined Decisions

Drive Results

Build Talent

Demonstrate Ethics and Integrity

Qualifications:

Bachelor s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting