Auftragsdetails

As a Consultant CQV, you will be responsible for the development, leading and executing of Commissioning and Qualification tasks within a variety of small to large scale projects. You may manage CQV projects individually as well as work within a multi-disciplinary team where you can have great influence and responsibilities.

You will ensure that the validated status of site facilities, utilities, equipment and processes, including cleaning, is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance/standards and provide expertise for the investigation and compliant resolution of non-conformances encountered during (re)qualification/(re)validation activities and site unplanned events.

Your assignments will vary from conceptual or basic design of new laboratories or manufacturing facilities to consultancy and advice on 
cleaning program management and improvement as well as technical audits. All work undertaken needs to be in accordance with 
the agreed budget, timescale, quality and performance criteria within the required procedures (health and safety, GMP, local and 
corporate standards). Primarily work will be at the premises of our clients, but occasionally from home or other remote location. With 
your extended experience in CQV and cleaning development and qualification you would be considered a great and valuable asset to 
our company. 

The Consultant CQV may develop CQV planning documents to manage CQV projects and generate and execute CQV protocols using Good Documentation Practices (GDPs). They may investigate and resolve protocol exceptions or discrepancies and develop technical reports and CQV summary reports. They also may read and verify facility, utility and equipment drawings (e.g., P&IDs), develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation. Performing risk and impact assessments may also be included

Who we are looking for:

Those who have a strong understanding of validation principles including but not limited to Facilities, Utilities, Equipment, Cleaning, Process, Computer Systems, etcetera and are able to work effectively as a part of a cross functional team while maintaining good relationships with internal and external stakeholders.

Qualified candidates must have:

• Bachelor’s or Master’s degree in Engineering, Science or related technical field. Advanced degree is desired.
• Solid science/engineering (8-12 years) experience, with specific experience within pharmaceutical, medical device, biotechnology or related industries.
• Expert knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.
• Expert knowledge of industry best practices for commissioning, qualification, validation, cleaning, analytical instruments and methods, etcetera.
• Expert knowledge and understanding of 21 CFR 210 & 211. 
• Expert knowledge of Microsoft Word, Excel, and other word processing programs as may be required by the Position (PowerPoint, Access, and Microsoft Project may be Required) including but not limited to Visio.
• General business math skills.
• Communicative and interpersonal skillset;
  • Customer oriented, passionate and able to effectively switch between different assignments;
  • Ambitious and enthusiastic relation builder with a quality driven mind-set;
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
  • Proficient in English language, both in speaking and in writing. Other language capabilities is desirable.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***