CQV Tech Transfer

Position: CQV Tech Transfer Specialist

Company Overview:

PharmEng Technology an Efor Group of Companies is a leading global provider of pharmaceutical consulting and project management services. With over 20 years of experience we have a proven track record of helping pharmaceutical companies achieve compliance improve efficiency and reduce costs. Our team of experts is dedicated to providing innovative solutions and exceptional customer service to our clients.

Position Overview:

We are currently seeking a CQV Tech Transfer Specialist to join our team in Barcelona Spain. This is a temporary position with the potential for extension based on project needs. The CQV Tech Transfer Specialist will be responsible for providing support to an API chemical manufacturing facility. This position requires the candidate to be in Barcelona 40 hours / week on site. A Minimum of 7 years postbachelors degree experience in a GMP functional area or support of a GMP functional area such as Operations or Technical Operations. Excellent command of English (both written and oral). Fluent native like Spanish.

Responsibilities include:

• Work with external partners to achieve business goals and to establish a common culture that benefits the company external partners and patients.

• Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.

• Responsible for technical transfer activities as applicable through review of GMP documentation (eg: Master Batch Records change control protocols reports qualifications etc.

• Responsible for technical activities for the commercial manufacturing process at the external partner which includes authorship of change control management of process improvement projects statistical analysis of process performance and investigation of atypical events.

• Develops solutions to complex technical issues that require a high degree of ingenuity creativity and innovation. Requires understanding and application of principles concepts practices and standards that govern the manufacturing of sterile products.

• Provide onsite coverage at external partner in support of commercial and / or tech transfer person in plant activities

• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations quality and external partners

• Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers in concert with operations quality and regulatory

• Responsible for participation in creating sharing and adopting best practices and business process strategies

Education Minimum Requirement:

• Bachelors degree in Chemistry Chemical/Biochemical Engineering Pharmaceutical Science or other related science or engineering field

Required Experience and Skills:

• Experience in API chemical manufacturing in an API manufacturing facility.

• Knowledge of GMPs in API manufacturing. A Minimum of 7 years postbachelors degree experience in a GMP functional area or support of a GMP functional area such as Operations or Technical Operations

• Experience in Quality Risk Assessments deviation management and change control.

• Strong analytical problemsolving skills root cause analysis and risk assessment/mitigation

• Experience in Tech Transfers

• Ability to work independently as well as excellent organizational skills.

• Strong professional and interpersonal communication skills

• Accomplishment oriented (selfmotivated and persistent) possess a business owner mentality possess the ability to influence without authority and demonstrate the ability to effectively operate in an ambiguous/changing environment.

• Must be able to multitask and work within tight deadlines.

• Proven collaboration and team building skills.

• Working Across Boundaries Must possess excellent interpersonal communication collaboration negotiation skills to work outside boundaries as a norm.

• Excellent command of English (both written and oral)

• Travel will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners)

Preferred Experience and Skills:

• Project management experience

• Knowledge of worldwide regulatory requirements experience supporting regulatory inspections.

• Experience in ADC manufacturing.