- 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 CAPA's 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
- Typical Minimum Education
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Typical Minimum Experience:
- 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
- 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
- Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all Carlow departments as they relate to ones 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
- Focus on Customers and Patients
- Collaborate
- Act with Candor and Courage
- Make Rapid, Disciplined Decisions
- Drive Results
- Build Talent
- Demonstrate Ethics and Integrity
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Process Support Specialist - Carlow, Ireland - PSC Biotech Ltd
Description
About PSC BiotechWho 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.
We are looking for a Process Support Specialist
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 requirements to ensure compliance, safety and reliable supply to our customers.
Principal Accountabilities:
Requirements
Skills and KnowledgeRequirements
Core Competences:
Technical
Business
