PPD

Quality Assurance Specialist II

Company
PPD
Location
Stevenage, United Kingdom
Salary
Competitive
Posted
20 Apr 2021
Closes
20 May 2021
Ref
1189234
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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 provides broad expertise to the department in one or more specialized areas, such as computer system audits, investigations, root cause analysis, batch record review, Total Quality Management (TQM), or other specialized areas/processes in the execution of the Quality Management System (QMS), which may include the performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at interdepartmental meetings related to the area of expertise. May serve as client coordinator for company contracted services for large/significant programs and contribute to policy-making decisions as a resource in area(s) of expertise.

You may serve as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g. reviews computer system validation data, lab investigations, root cause analysis, batch record review or total QualityManagement.
  • Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D
  • Assure products meet regulatory requirements and that they conform to regulatory submissions.
  • May interact with regulators.
  • May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
  • May lead a project, program or team activities which may include GxP.
  • May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports.
  • Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
  • Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
  • Provide advice and consultancy to Client project teams and external partners to reduce regulatory risk to the Client.
  • May represent the group as a primary business contact for specific areas.
  • Identify and mitigate compliance risks to the Client through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.
  • Liaise with customers to provide compliance advice/input.
  • Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
  • Establish improvement processes, as needed, or set specific measurable targets and goals linked to the Client business needs.
  • Communicate and interact at various levels internally and externally to the Client.
  • Build and maintain effective internal Client business relationships within business units

Responsibilities:

• Approve GMP documentation, including Standard Operating Procedures, validation documentation, change controls, and other controlled documents from business partner areas.
• Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
• Perform internal assessments to measure compliance with appropriate Client policies and procedures.
• Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment procedures.
• Initiation and maintenance of Quality Assurance Agreements
• Develop and deliver GxP training to business partners.
• Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
• Generate, review and approve batch and/or packaging record templates.
• Conduct review ofcompleted batch and/or packaging records.
• Perform material release activities (US Only)
• Ensure that the third party assessments are available to support material release
• Generate and approve relevant release documentation
• Provide project support including pre approval audit activities.

*LI-SW1

Qualifications:

Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
    Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job
    (comparable to 5+ years).

Knowledge, Skills and Abilities:
• Strong expertise in one or more specialized areas relevant to QA activities, e.g. computer systems,
root cause analysis, TQM, batch record review, vendor management, CAPA, risk assessment
• For laboratory positions, may require knowledge of chromatography, immunochemistry or statistics
• Thorough knowledge of GxP and appropriate regional regulations and guidelines. GMP or GCP experience is also desired.
• Demonstrated proficiency in leading a range of project based or internal GxP audits and vendor
audits
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis and CAPA management
• Strong negotiation and conflict management skills
• Ability to remain flexible and and prioritize competing demands/work load

Working Conditions:
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 for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

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