Scientific Technical Writer II - Pds

Summary:

Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, support and assistance to the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Work with Engineering groups to maintain MBR templates. Lead and participate in improvement initiatives to support the site as well as improve processes within the Technical Writing department. Act as subject matter expert in relation to revising and creation of master batch records and labels, as well as change controls.

Essential Functions:

Master Batch Records (MBR) Generation

• Understand all requirements to generate and develop all master batch records working closely with Commercial / Pharmaceutics & Process Technology departments, Technical Project Leaders and Project Managers in the generation and approval of Master Batch Records (MBR's).
• Update and maintain master records and directories ensuring that records are updated as per current requirements.
• Follow production schedule requirements.
• Prepare planned deviations, execute action items to facilitate manufacturing and packaging activities.
• Develop bill of materials for new products. Verify accuracy of bill of materials and item master information that has been entered into the computer system as it applies to packaging components.
• Create and ensure the most current approved Shipper Labels and Shelf Pack Labels are located in the "master" directory.
• Generate and update Shipper Fill Diagram and Pallet Pattern as per packaging instructions.
• Coordinate the official sign off circulation and implementation of Master Manufacturing and Packaging Records.
• Control, compile and maintain Product Technical Files for all products.
• Control access to MBR'S. Provide current Master Records to Planning and maintain the MBR data base.
• Generate and revise Change Control to master records and generation of new Master Records.

• Issue batch records ensuring all planned deviations noted as required.
• Assist Technical Project Leaders with batch record set-up and other Manufacturing and Packaging issues.
• Attend key project team meetings, client teleconferences and on-site visits.
• Assist Technical Project Leaders in the generation of protocols, reports and assessments.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

College Diploma in Science/Technical related field (Food or Drug)

B.Sc. an asset

Experience:

Minimum of 3 years related experience with report writing and batch record preparation preferred.

Equivalency:

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

Knowledge, Skills and Abilities:

Strong written and oral communication skills. Good technical skills and capability to understand different manufacturing and packaging processes. Well organized and detail oriented. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Experience in managing multiple priorities. Self motivated and able to work independently. Proficiency using MS Office, particularly Microsoft Word and Excel. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively 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 Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). 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 identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

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 regular 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 on occasionally.