Process Validation - Materials Qualification

Essential Duties and Responsibilities

Azzur personnel are expected to always live up to our core values and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project.  The level of knowledge expected will be commensurate with level of incoming experience.

• Generate and manage Material Qualifications
• Ensure that all qualifications and validations are performed according to the regulatory and customer requirements
• Be able to support Quality by Design on the drugs to be transferred or developed on the site
• Write qualification and validation protocols/reports and other documentation related to the activities
• Validation of aseptic process (formulation, filling, holding times)
• Participate to shutdown qualification & calibration activities
• Investigate deviations as needed and execute corrections
• Define and execute improvement projects and initiatives
• Ensure that all activities are performed in time and due quality

Ideal Qualities

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

• Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
• Willing to work hands on with multiple clients throughout Southern California
• Ensures activities are efficient, optimized, and client centric. 
• Highly motivated and organized, solutions-oriented leader
• Curious and adaptable - can transform knowledge into actionable activities
• Able to produce results in a fast paced, collaborative environment   

Qualifications

• BS in Engineering, Science, or equivalent technical degree.
• 3-5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
• Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
• Excellent written and verbal communication skills; excellent technical writing skills.
• Strong interpersonal skills and the ability to work in a team environment.
• Ability to work effectively in a fast-paced multitasking environment.
• Strong working knowledge of FDA and cGMP regulations and documentation practices.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Working for multiple clients throughout the region.

About Azzur

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.

No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works together with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.

With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory and validation services specifically geared for the complexities of life science.

Do What You Love

We are seeking highly motivated individuals that have the desire to learn, can adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for everyone through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.

If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!

Perks of Working at Azzur

• Medical, Dental and Vision
• Competitive 401K plan
• Flexible Paid Vacation Time
• Employee Recognition Program
• Diversity and Inclusion Initiatives
• Training and Mentorship Opportunities

Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ

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