CQV Specialist

Hiring By - Biostaffic

 BioPharma

United Kingdom

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
I'm currently recruiting a Validation Specialist on behalf of one of our clients, a very well known biotech organisation.
About The Role
As a CQV Specialist, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and facilities. Working closely with cross-functional teams, you will be responsible for the commissioning, qualification, and validation of equipment, systems, and processes to meet regulatory requirements and industry standards.
Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Perform risk assessments and impact assessments to ensure comprehensive validation strategies.
  • Collaborate with engineering, manufacturing, quality, and regulatory teams to ensure alignment and compliance with cGMP guidelines and regulatory requirements.
  • Lead validation activities for new equipment installations, process improvements, and facility expansions.
  • Execute validation studies, including but not limited to equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and computer system validation.
  • Analyze validation data, generate reports, and make recommendations for process improvements and corrective actions.
  • Support regulatory inspections and audits by providing documentation and participating in inspections as necessary.
  • Stay informed about current industry trends, regulatory expectations, and best practices related to validation and compliance.
Qualifications
  • Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
  • Minimum of 2 years of experience in commissioning, qualification, and validation within the biotech or pharmaceutical industry.
  • Strong understanding of cGMP regulations.
  • Experience with validation documentation, including protocols, reports, risk assessments, and standard operating procedures (SOPs).
  • Excellent analytical, problem-solving, and decision-making skills.
  • Ability to work effectively in a fast-paced, dynamic environment with multiple priorities and tight deadlines.
  • Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • United Kingdom

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
Adecco
Adecco

Current Openings: 0

Adecco ist in 60 Ländern vertreten und zählt zu den zehn größten Arbeitgebern weltweit. Wir haben es zu unserer Aufgabe gemacht, eine Brücke zwischen Unternehmen und Menschen zu schlagen. In unseren verschiedenen Geschäftsbereichen, wie zum Beispiel Industrial und Office, konzentrieren wir uns auf die spezifische Personalentwicklung für unsere Kunden – vom Mittelständler bis zum internationalen Konzern. Kerndienstleistungen sind Arbeitnehmerüberlassung, Personalvermittlung, Inhouse Outsourcing, Consulting, OnSite Management sowie Arbeitsschutz und Prävention. Durch das hauseigene Personalentwicklungsprogramm „Adecco Career Up“ verfügen wir über eine außergewöhnliche Expertise in der Mitarbeiterqualifizierung. Als Tochterunternehmen der internationalen Adecco Gruppe mit Sitz in der Schweiz sind wir ein Teil des Weltmarktführers unter den Personaldienstleistern. Mit mehr als 5.100 Niederlassungen in allen Ländern und Regionen rund um den Globus bietet die Adecco Gruppe ein breites Spektrum an Personaldienstleistungen und verbindet täglich mehr als 700.000 Arbeitskräfte mit über 100.000 Unternehmen. Sämtliche Bezeichnungen richten sich an beide Geschlechter.
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