Instrument Qualification Specialist in a GMP setting

Submission for the position: Instrument Qualification Specialist in a GMP setting - (Job Number: 185611)

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

In this position you will be responsible for assisting analytical instrument owners, to navigate through the requirements of the GMP instrument program from qualification to decommissioning. This includes, but is not limited to qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival. Responsibilities include collaboration with the quality unit to insure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards. Collaborating with external contract service providers to ensure the requirements of the GMP instrument program are met. Provide support to the Analytical Strategy & Operations (ASO) management team in internal and external audit inspections. In addition, the candidate will be responsible for continuing to drive the transition from instrument paper logbooks to an electronic instrument logbook.

*LI-SW1

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

In this position you will be responsible for assisting analytical instrument owners, to navigate through the requirements of the GMP instrument program from qualification to decommissioning. This includes, but is not limited to qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival. Responsibilities include collaboration with the quality unit to insure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards. Collaborating with external contract service providers to ensure the requirements of the GMP instrument program are met. Provide support to the Analytical Strategy & Operations (ASO) management team in internal and external audit inspections. In addition, the candidate will be responsible for continuing to drive the transition from instrument paper logbooks to an electronic instrument logbook.

*LI-SW1

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8 years’) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities: Minimum of 2 years’ experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role. At least one year of experience in a GMP regulated lab is required. Demonstrated expertise in large projects within a complex high performance team, Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software Knowledge of laboratory GMP principles (21CFR Part 210/Part211) and Good Documentation Practices (GDP) is required. Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects. Self-directed with a high degree of professional integrity, organization, and attention to detail. Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Ability to work across timelines and be available to travel when required. De monstrated use of flexible thinking and growth mind-set is an advantage.

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5-8 years’) or equivalent combination of education, training, and experience.

Knowledge, Skills and Abilities: Minimum of 2 years’ experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role. At least one year of experience in a GMP regulated lab is required. Demonstrated expertise in large projects within a complex high performance team, Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software Knowledge of laboratory GMP principles (21CFR Part 210/Part211) and Good Documentation Practices (GDP) is required. Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects. Self-directed with a high degree of professional integrity, organization, and attention to detail. Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision. Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Ability to work across timelines and be available to travel when required. De monstrated use of flexible thinking and growth mind-set is an advantage.

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Submission for the position: Instrument Qualification Specialist in a GMP setting - (Job Number: 185611)