Technical Writer II - Technical Operations

Business Title : Technical Writer II Technical Operations

Effective Date : Revision # : 1

Revision # : 1

Version # : , CURRENT

Replaces : Summary :

Summary :

Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, supports and assistances the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups.

Assist with maintaining up to date MBR templates and completes improvement projects related to technical writing.

Essential Functions :

Work closely with the Technical Operations, PPT Engineers and commercial departments in the generation and approval of work orders.

Work with internal teams addresses client comments

Generate and develop all master batch records used in Good Manufacturing Practices environment.

Work closely with Engineers, Business and Project Managers to understand requirements for each MBR.

Attend key project team meetings, client teleconferences and on-site visits.

Create change controls and attends CC committee meetings

Assist Technical Operations and PPT group as the need arises.

May be required to assist with report generation from Systems, Applications and Products (SAP).

Update and maintain MBR templates to comply with current practices in Operations and PPT

Maintain a safe working environment and reports potential hazards.

Perform alternating or rotating shift work (as the need arises)

REQUIRED QUALIFICATIONS

Education :

College Diploma in Science / Technical related field.

Experience :

Minimum 3 years related experience.

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities :

Strong written and oral communication skills. Must be well organized and detail oriented. Ablity to to lead improvement projects.

Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines.

Proficiency with Microsoft Office applications. Proficiency with the English Language.

Standards and Expectations :

Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.

Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.

Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets).

Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving.

Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.

Proactively identifies areas for improvement in the execution of department procedures. Communicate risks to timelines of deliverables in a proactive manner.

Consistently strives to improve skills and knowledge in pharmaceutical development (an asset).

Physical Requirements :

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment.

Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights.

Use of Personal Protective equipment may be required and may include any of the following : safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.