Summary:
Supports the Technical Operations department in generation of protocols, master batch record review, batch analysis, Quality Investigation Report/Quality Deviation Report (QIR/QDR) follow-up, process execution and equipment procurement.
Essential Functions:
§ Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization.
§ Investigates quality issues could include system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR).
§ Investigates root causes and recomments appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc).
§ Generates technical documents (protocols, reportes, proposals, gap/risk assessment, batch records, URS, etc).
§ Generates, assesses, and approves change controls.
§ Attends Quality Improvement meetings.
§ Assists in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC) and Commercial Operations.
§ Supports Technical Operations team with process execution/equipment trials and design and acquistion of equipment.
§ Performs batch analysis.
§ Attends project team meetings, client teleconferences and on-site visits.
§ Daily interactions with clients.
§ Works closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities and attends weekly scheduling meetings (if applicable).
§ Provides training/support to Co-Ops/Interns and monitors ongoing training (if applicable)
§ May be essential to perform alternating or rotating shifts (as required)
REQUIRED QUALIFICATIONS
Education:
Minimum post secondary diploma in Chemistry, Engineering, Science or related field.
BSc in Chemistry or Engineering is an asset.
Experience:
3+ years of experience within Pharmaceutical Manufacturing or Quality Assurance departments
2+ years of combined hands on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).
1+ year experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required
Previous experience in statistical analysis and data compilation an asset.
Previous experience with SAP enterprise software to source information and navigate business operations an asset.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Knowledge of processing/packaging equipment. Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures. Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills and communication skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Proven
problem solving abilities. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
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