Technician

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.

Requirements

1.0 Job Purpose:

1.1 Responsible for supporting the Quality Department in the management of the site GMP documentation, and in supporting the Quality functions in various administrative duties.

1.2 Ensure that objectives are effectively achieved, consistent with our requirements to ensure Compliance, safety and reliable supply to our customers.

2.0 Principal Accountabilities:

o Responsible for the control, operation and maintenance of the site Central Documentation Control system.

o Be a document system expert; this will include document, review, approval and document system work flow oversight. e.g. SOPs, work instructions, master forms etc. Support documentation generation, review and approval in line with the standard approval process.

o Support site activities through maintenance/ monitoring of associated databases including MEDS, Quality Docs etc.

o Establish and effectively manage information management systems, develop reports, presentation, projects, timelines and correspondence utilising many different computerised systems when and if required .

o Use standard systems including MS Word, Excel, PowerPoint, Outlook and various company and industry specific software.

o Issuance and reconciliation of controlled documents to support site activities.

o Support department/site to be audit ready.

o Facilitate site wide awareness of GMP activities; may be facilitated by means such as effective use of communication forums, development and facilitation of training programmes.

o Coordinate & manage special projects within the area/division.. Complete department specific assignments; including SOP administration; coordination of training, GMP Document Tracking; information repository coordination and compliance etc as required.

o Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate.

o 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.

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

o May be required to perform other duties as assigned.

3.0 Skills and Knowledge

3.1 Typical Minimum Education:

Diploma preferred; ideally in a related discipline

3.2 Typical Minimum Experience:

Experience and/or a particular skill set in their area of expertise that adds value to the

Business; ideally in a manufacturing, preferably GMP setting.

4.0 Core Competences:

4.1 Technical:

• 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
  
• Understanding of Lean Six Sigma Methodology preferred
  

4.2 Business:

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

Ability to work with teams and escalate issues to management in a proactive manner

Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports

Customer service

Goal/results orientated

Training skills

Effective time management and multi-tasking skills

Proven organizational skills

Excellent attention to detail

Self motivated

Flexible approach

Trouble shooting skills

1.0 Job Purpose: 1.1 Responsible for supporting the Quality Department in the management of the site GMP documentation, and in supporting the Quality functions in various administrative duties. 1.2 Ensure that objectives are effectively achieved, consistent with our requirements to ensure Compliance, safety and reliable supply to our customers. 2.0 Principal Accountabilities: o Responsible for the control, operation and maintenance of the site Central Documentation Control system. o Be a document system expert; this will include document, review, approval and document system work flow oversight. e.g. SOP's, work instructions, master forms etc. Support documentation generation, review and approval in line with the standard approval process. o Support site activities through maintenance/ monitoring of associated databases including MEDS, Quality Docs etc. o Establish and effectively manage information management systems, develop reports, presentation, projects, timelines and correspondence utilising many different computerised systems when and if required . o Use standard systems including MS Word, Excel, PowerPoint, Outlook and various company and industry specific software. o Issuance and reconciliation of controlled documents to support site activities. o Support department/site to be audit ready. o Facilitate site wide awareness of GMP activities; may be facilitated by means such as effective use of communication forums, development and facilitation of training programmes. o Coordinate & manage special projects within the area/division.. Complete department specific assignments; including SOP administration; coordination of training, GMP Document Tracking; information repository coordination and compliance etc as required. o Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. o 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. o Work collaboratively to drive a safe and compliant culture in Carlow. o May be required to perform other duties as assigned. 3.0 Skills and Knowledge 3.1 Typical Minimum Education: Diploma preferred; ideally in a related discipline 3.2 Typical Minimum Experience: Experience and/or a particular skill set in their area of expertise that adds value to the Business; ideally in a manufacturing, preferably GMP setting. 4.0 Core Competences: 4.1 Technical: 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 Understanding of Lean Six Sigma Methodology preferred 4.2 Business: Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers, in a team orientated manner Ability to work with teams and escalate issues to management in a proactive manner Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports Customer service Goal/results orientated Training skills Effective time management and multi-tasking skills Proven organizational skills Excellent attention to detail Self motivated Flexible approach Trouble shooting skills