West Pharma Technical Investigator 

Ireland, Dublin 

667367496

Job Summary:

Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.

Essential Duties and Responsibilities:

• Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
• Responsible for completion of investigations in compliance with Quality standards
• Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance
• Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business
• Ensures that investigations comply with the Quality standards implemented in the business
• Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs
• Participates in regulatory inspections to present and defend investigations when required.
• Ensuring the timely and effective closure of day-to-day quality issues.
• Proactively improve processes to deliver competitive advantage for both the Business and customer
• Coach and drive a culture of compliance and continuous improvement.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor

Basic Qualifications:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment

Preferred Knowledge, Skills and Abilities:

• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have excellent technical writing skills.
• Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3
• Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Must have excellent communication skills both oral and written.
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to deal with all levels of employees and work across various departments

Travel Requirements:

• Must be able to travel up to 5% of the time or when required

Physical & Mental Requirements:

• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; be detail orientated and self-motivated.
• An ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Must be able to work independently on own projects while working concurrently with all departments.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.

Competencies/Authorities

Delegation of Duties:

• When absent from the site duties and responsibilities will be delegated to the following designates

Value Stream lead- Operations

Job Summary:

Reporting to the Value Stream Lead within Operations this role ensures effective problem solving and closure of non-conformances within compliance to the Quality Management System.

Essential Duties and Responsibilities:

• Objectively facilitating cross functional teams to the correct identification of the root cause and identifying robust corrective and preventive actions to avoid reoccurring problems and investigations.
• Responsible for completion of investigations in compliance with Quality standards
• Utilizing lean tools and problem-solving tools while improving the problem-solving process, for the enhancement of site processes and performance
• Responsible for gathering, trending and analysing data to accurately clarify problems and identify continues improvements across the business
• Ensures that investigations comply with the Quality standards implemented in the business
• Responsible for clearly documenting investigations within the required timeframes to meet business and compliance needs
• Participates in regulatory inspections to present and defend investigations when required.
• Ensuring the timely and effective closure of day-to-day quality issues.
• Proactively improve processes to deliver competitive advantage for both the Business and customer
• Coach and drive a culture of compliance and continuous improvement.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor

Basic Qualifications:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 3+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment

Preferred Knowledge, Skills and Abilities:

• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Moulding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have excellent technical writing skills.
• Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3
• Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Must have excellent communication skills both oral and written.
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets.
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Must be able to deal with all levels of employees and work across various departments

Travel Requirements:

• Must be able to travel up to 5% of the time or when required

Physical & Mental Requirements:

• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; be detail orientated and self-motivated.
• An ability to collaborate across functional teams and work effectively in a matrixed team environment.
• Must be able to work independently on own projects while working concurrently with all departments.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.

Competencies/Authorities

Delegation of Duties:

• When absent from the site duties and responsibilities will be delegated to the following designates

Value Stream lead- Operations