Overland Park, KS

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

As a Consultant, you will be responsible for the development, leading and executing of Commissioning and Qualification tasks, with a focus on discrepancy investigations, risk assessment, CAPA development and other related tasks. You may work within a variety of small to large scale projects. You may manage 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, discrepancy investigations, risk assessment, CAPA development and other related tasks 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 discrepancy investigations, risk assessment, CAPA development and other related tasks, as well as process improvements and 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 discrepancy investigations, risk assessment, CAPA development and other related tasks you would be considered a great and valuable asset to our company.

The Consultant may develop planning documents to manage projects and generate and execute protocols using Good Documentation Practices (GDPs). They may investigate and resolve protocol exceptions or discrepancies and develop CAPA’s, risk assessments, technical and 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

Qualifications

Those who have a strong understanding of validation principles including but not limited to Facilities, Utilities, Equipment, Cleaning, Process, Computer Systems, etcetera, along with discrepancy investigations, risk assessment, CAPA development and other related tasks. Working effectively as a part of a cross functional team while maintaining good relationships with internal and external stakeholders will be very important.

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 of discrepancy investigations, risk assessment, CAPA development and other related tasks.
• 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.

Additional Information

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.***