Product Support Investigator

4 months ago


Dundee, United Kingdom Digby Morgan Full time

summary
- _ dundee, scotland_
- _ £12.82 per hour_
- _ temporary_- specialism
- pharmaceutical- sub specialism
- quality- reference number
- PR-1257602
- job details

Job Title: Product Support Investigator

Location: Dundee

Pay rate: £12.83

Work days: Mon-Fri

Shift Pattern: 08:30 - 16:30

Main Purpose of Role:
...
- The Product Support Investigator is responsible for logging, assessing the reportability of end-user complaints, and conducting investigations in accordance with site procedures and regulations.Main Responsibilities:

- Log, acknowledge, and assess alleged product deficiencies from end users for adverse event reportability within specified timelines.
- Conduct thorough investigations to identify and report the cause of reported issues.
- Manage Supplier Corrective Actions (SCARS) received and ensure timely resolution.
- Contribute to continuous improvement initiatives and general housekeeping duties to enhance operational efficiency.
- Engage in ongoing professional development and site training initiatives.
- Foster excellent relations within the department team and broader Operations group to ensure effective collaboration.
- Propose ideas and initiatives to enhance communication and productivity within the team.
- Adhere to relevant policies and procedures outlined for the role.

Qualifications:
**Education**:

- Bachelor's degree in Biological Sciences or related field.

Experience/Background:

- Minimum 3 years of practical experience in an IVD (In Vitro Diagnostics) manufacturing environment.
- 3 years of experience within life sciences or similarly regulated industry, with exposure to In-Vitro Diagnostics preferred.
- Proficient in complaint logging and investigation of IVD product deficiencies per ISO 13485:2016 standards.
- Experience with complaint management software, with preference for SFDC.
- Proficient in Root Cause Analysis (RCA) tools, including A3/DMAIC methodologies.
- Ability to contribute to Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
- Familiarity with Enterprise Resource Planning (ERP) systems and Electronic Document Management Systems (EDMS).
- Experience with Corrective and Preventive Action (CAPA) systems, with Agile experience preferred.
- Strong proficiency in MS Word, Excel, and PowerPoint.
- Hands-on experience running IVD tests such as Immunoassay and Clinical Chemistry.

Note: Preferred qualifications are indicated where applicable.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.

show more

Job Title: Product Support Investigator

Location: Dundee

Pay rate: £12.83

Work days: Mon-Fri

Shift Pattern: 08:30 - 16:30

Main Purpose of Role:
The Product Support Investigator is responsible for logging, assessing the reportability of end-user complaints, and conducting investigations in accordance with site procedures and regulations.

Main Responsibilities:

- Log, acknowledge, and assess alleged product deficiencies from end users for adverse event reportability within specified timelines.
- Conduct thorough investigations to identify and report the cause of reported issues.
- Manage Supplier Corrective Actions (SCARS) received and ensure timely resolution.
- Contribute to continuous improvement initiatives and general housekeeping duties to enhance operational efficiency.
- Engage in ongoing professional development and site training initiatives.
- Foster excellent relations within the department team and broader Operations group to ensure effective collaboration.
- Propose ideas and initiatives to enhance communication and productivity within the team.
- Adhere to relevant policies and procedures outlined for the role.

Qualifications:...
- Education:
- Bachelor's degree in Biological Sciences or related field.

Experience/Background:

- Minimum 3 years of practical experience in an IVD (In Vitro Diagnostics) manufacturing environment.
- 3 years of experience within life sciences or similarly regulated industry, with exposure to In-Vitro Diagnostics preferred.
- Proficient in complaint logging and investigation of IVD product deficiencies per ISO 13485:2016 standards.
- Experience with complaint management software, with preference for SFDC.
- Proficient in Root Cause Analysis (RCA) tools, including A3/DMAIC methodologies.
- Ability to contribute to Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
- Familiarity with Enterprise Resource Planning (ERP) systems and Electronic Document Management Systems (EDMS).
- Experience with Corrective and Preventive Action (CAPA) systems, with Agile experience preferred.
- Strong proficiency in MS Word, Excel, and PowerPoint.
- Hands-on experience running IVD tests such as Immunoassay and Clinical Chemistry.

Note: Preferred qualifications are indicated where applicable.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.

show more



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