Senior Associate QA Specialist ( 12 months FTC)

Corporate        ·      Sittingbourne, United Kingdom  ·       Full time

• Locations: Sittingbourne, United Kingdom
• Categories: Corporate
• Req ID: 10398

Job Description

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Job Purpose

• To assist the Quality Department in implementation of the Quality System at the KSP facility and associated contractor sites.
• To work with all necessary departments to ensure the GMP and GACP system is current and in compliance with the current guidelines and company filings to produce product fit for the intended use by a patient.
• To review and work to continuously improve compliance within the KSP facilities through promoting QA and developing sustainable quality systems as directed by the Quality management team.

Key Responsibilities/Accountabilities

The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

• Daily
  • To assist the QA department in implementing and maintaining the Quality System at all GW and Contractor sites.
  • Reviewing batch records or validation documentation ensuring that they are clear, complete, and in compliance with company procedures, regulatory requirements, marketing partner requirements and GMP requirements prior to final review and release. This may include (once trained) Milling, Bulk Drug Substance (BDS), API (in-house and CMO manufactured), Bulk Drug Product (BDP) and finished product. The review should be to agreed timelines.
  • Perform the QA disposition of intermediates and products (once trained and as permitted by local procedures).
  • Day to day training, mentoring and supporting of junior members of the department.
  • Monitoring and continuously improving quality metrics (KPI) relevant to the area of specialism. Assisting in the achievement of acceptable levels of performance through training, regular area visits, and influencing others in all departments on site.
• Periodic/as required
  • Leading and supporting departmental investigations (including deviations, out of specifications, and complaints) ensuring that they are fully documented, that the root cause has been determined, and that corrective and preventative actions have been introduced, or initiated, as agreed and on time.
  • Lead or support audits (Internal and external) as required supporting the KSP audit programme.

Detailed Responsibilities/Accountabilities

• HSE
  • Ensures that activities under their control are carried out in ways to minimize risks to health, safety and security or the environment and reports any shortcomings in GW arrangements.
• Training
  • Ensures training records are kept up to date.
• Executed Batch Document Review (once trained in each)
  • Performs the QA review of executed batch records (Milled, BDS, API, BDP and Finished product) and validation documentation.
• Batch Disposition
  • QA disposition of stock (as approved by local procedures).
• Artwork
  • QA review of master artwork.
• Compliance
  • Reporting compliance failures or unusual trends.
  • SOP documentation for QA and other departments.
  • QMS trending.
• Supporting Responsibilities
  • Provides regular status updates of current work/projects.
  • Provides QA technical support in area of specialisation (including line checks and area clearances as required).
  • Author or assisting with other documentation review as required (includes validation, qualification, calibrations, failed calibrations, deviations, 00S, CAPA, change control and complaint investigations).
  • Author or assisting with the assembly of Product Quality Review (PQR) sections or summaries including trending the QMS and collating data for the annual QA report as required.
  • Approval, author, or assisting with other documentation including protocols, SOPs, deviations, OOS, CAPA file notes, or master documents.
  • Can sign documents (“pp”) on behalf of other QA personnel in time of absence, and where training and experience allows.
• Auditing and Due Diligence
  • Internal auditing of departments/systems within KSP as experience and training allows. May take part in external audits as experience and training allows.
  • Ensuring any investigations that could lead to a product recall are brought to the immediate attention of senior staff (including Qualified Persons (QPs) and the Site Director of Quality).
  • Ensuring that regulatory, marketing partner, Due Diligence and other audits/inspections performed at GW are supported with efficient document retrieval and supply of technical information
• CAPA
  • To ensure CAPAs are promptly raised following identification of need, have appropriate due dates and are completed by date required with supporting evidence.
• Other support activities
  • General QA support activities
  • To undertake other activities as required by the QA team
  • Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence.
  • Actively looks for and implements improvements in productivity and efficiency within own work area
  • Works in accordance with the systems in place with regards to health & safety, security and the environment
  • Undertakes other activities, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/GQLT

Key Attributes/Skills/Education – Essential

Knowledge:

• Typically Bachelor’s degree in science or related discipline
• Post-graduate qualifications (Master’s, PhD) highly regarded

Experience:

• Typically >3 year post-degree work experience in a GMP environment
• Knowledge of Quality Systems in the Pharmaceutical Industry is preferred
  • Specifically including technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing

Skills:

• Working knowledge of office IT packages
• Good level of written and verbal communication skills
• Excellent attention to detail
• Ability to manage time/workload through effective prioritisation
• Working knowledge of Microsoft office packages

Attributes and Behaviours:

Proven organisational and interpersonal skills, demonstrated through the following competencies:

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services.
• Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn’t misrepresent him/herself for personal gain.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative.
• Functional/Technical skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Action Orientation: Enjoys working hard; is action orientated and full of energy for things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities that others.
• Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product or technical knowledge; does well in technical courses and seminars.
• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Presentation Skills: Is effective in a variety of formal presentation settings: one-on-one, small and large groups, with peers, direct reports, and bosses; is effective both inside and outside the organisation, both of cool data and controversial topics; commands attention and can manage group processes during the presentation; can change tactics midstream when something isn’t working.
• Problem Solving: uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.
• Self development: Is personally committed and actively works to continuously improve him/herself; understands that different situation and levels may call for different skills and approaches; works to deploy strengths; works on compensating for weakness and limits. 

Key Attributes/Skills/Education – Desirable

• Develops and maintains positive working relationships with colleagues within and outside of department boundaries.
• Promotes the quality assurance role throughout GW Pharmaceuticals positively, challenging incorrect behaviours in others and acting as point of contact and ambassador for their area of specialism.
• Excellent interpersonal skills and the ability to work as part of a team or independently to agreed deadlines.
• Supervises colleagues within their team as required.

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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