Technical Writer - Supply Chain Serialization

Description:

•  Key contributor of Serialization team
• Assist with developing specifications as needed for equipment / systems
• Support equipment installation and shakedown of new equipment relevant to manufacturing, packaging and utility systems
• Provide input to test parameters, process parameters, validation documentation
• Support documentation generation
• Support process development for systems and equipment
• Develop critical parameters needed for follow up validation testing of equipment
• Perform basic to high-level mathematical calculations to support process development
• Monitor manufacturing and packaging processes during initial production run to assess any technical process issues. 
• Assist in composing process optimization protocols. 
• Clearly and accurately document activities. 
• Provide input to Master Batch Records (MBRs). (equipment, critical process parameters, in-process tests, etc.) 
• Assist technicians in performing physical testing during the manufacturing and packaging operation (e.g. sieve analysis, tap and bulk density, cap torque testing, etc.).
• Work with multi-functional team to meet goals and achieve results

Experience:

• Serialization experience required.
• Provide support for developing and/ or revising Standard Operating Procedures, Forms, and Work Instructions for SAP ATTP and ICH software application.
• Work closely with serialization team and internal business counterparts to ensure documentation meets business process requirements and meets regulatory timelines and deliverables.
• Identify and support organizational change.

• B.S. in Engineering, Pharmacy or Chemistry or related scientific degree.
• 2+ years in pharmaceutical manufacturing environment or equivalent regulated industry.
• Basic understanding of pharmaceutical manufacturing and packaging equipment and processes.
• Basic understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of pharmaceutical processes spanning the entire product life-cycle.
• Basic understanding of applicable SOPs.
• Basic understanding of safety policies.
• Safety - Ability to wear Personal Protective Equipment as required. Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers.
• Regulatory Compliance – The ability to work in a regulated environment (FDA, DEA, OSHA, etc.) and strictly follow procedures. 
• Communication – Strong and effective verbal and written communication.  Ability to read and comprehend detailed written instructions. 
• Performance – self-motivated and able to follow instructions from project lead(s).
• Documentation – Clearly and concisely document all work activities in a timely manner utilizing existing forms and records.  Writes legibly. 
• Data Handling –Basic computer skills. Collect data, conduct comparative and statistical evaluations and present it in a professional manner including graphs and charts. 
• Client Interaction – Will interact with clients on a regular basis. 
• Teamwork – Ability to work effectively within a team environment.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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