Technical Writer I – Operations

Summary :

Prepare and revise Standard Operating Procedures (SOPs) based on Deviation Reports(DR) / Corrective Action Preventative Action (CAPA) and Change Control (CC) initiatives within the operations department. Assist Production Management (Processing or Packaging) groups through completion of administrative tasks as assigned.

Essential Functions :

Quality Documents

Review, revise and prepare procedures / SOPs for compliance to Good Manufacturing Practices (GMP) and to reflect current work activities in Operations department

Ensure procedures / SOPs for Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. In particular, procedures in response to Bi-Annual Reviews, DRs, comments / audits by clients and regulatory agencies, change controls (CCs), new / modified equipment, and general changes in procedures

Ensure procedures / SOPs are regularly reviewed and kept up to date with proper approvals

Work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided

Work closely with Technical Operations, PPT Engineers and processing and packaging departments in the generation and approvals of SOPs and CCs.

Work closely with quality and investigations to understand requirements for each CAPA / DR / SOP.

Track status of in-process SOPs, training, and other activities.

Create change controls.

Department Contributions

Work with Operations Personnel to identify process improvements.

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

Support production department with logbook system, retrieval and management for audits and storage purposes.

Act as a back up to any department coordinators

Perform alternating or rotating shift work (as required)

Maintain a safe working environment and report potential hazards.

Maintain a personal project list of assignments with target completion dates.

Metrics

Collect and analyze Operations Administration metrics and identify potential projects / solutions

REQUIRED QUALIFICATIONS

Education :

College / Technical School diploma in pharmaceutical manufacturing, science or related field.

Bachelors of Science or Bachelor of Applied Science or related field an asset

Experience :

2 years of related pharmaceutical experience, preferably in a Manufacturing environment

Previousexperience leading training in the pharmaceutical industry (an asset).

Equivalency :

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

Knowledge, Skills and Abilities :

Knowledge of cGMP requirements, ability to follow Standard Operating Procedures (SOPs) and pharmaceutical processing regulations. Strong team building and organization skills. Excellent computer skills, including the ability to develop spreadsheets, presentations and reports. Excellent written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills. Proficiency with Microsoft Office. 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. Effectively 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. Model 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 :

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab / lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.