Job Purpose
The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).
Duties And Responsibilities
- Perform Assay, Impurities, In-Vitro & Cleaning method developmental and validation study using HPLC, GC and other instrumental techniques.
- Ensure all routine analysis related with Bulk, Finished Product and stability sample are completed within deadline
- Perform method verification, compendial update & method transfer activities.
- Participate on projects in the area of focus related to process improvement.
- Collaborate with other departments to proactively build quality into the processes and systems.
- Create and revise QC procedures as required.
- Provide support for internal and Regulatory Inspections.
- Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
- Generate, gather and analyze data for reporting purposes.
- Complete all GMP Documentation correctly and in a timely manner.
- Ensure OOS/OOT & CAPA’s are completed within timeline.
- Initiate, and follow through with actions required to close Change Controls.
- Participate in Internal, Customer and Regulatory Audits.
- Maintain a clean laboratory environment and ensure that safety regulations are followed
- Complete all training assignment and maintain personal training records.
- Flexibility to work shift schedules when required
- Support new product launch.
- Other duties as assigned by manager
Additional Responsibility (Only Applicable To Customer Facing Roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
- Bachelor’s Degree in Chemistry, or related discipline
- 3-5 years’ method validation, method verification & method transfer experience in the pharmaceutical laboratory.
- Demonstrated technical writing skills
- Well-developed interpersonal and teamwork skills
- Expert knowledge and understanding of analytical chemistry and instrumentation
- Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC)
- Knowledge of applicable software including LIMS, Empower and MS Office
- Sound knowledge and application of Health Canada and FDA regulations
- Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
- Excellent written communication and report writing skills
- Strong organizational skills and ability to multi-task; detail oriented
- Advanced ability in investigative techniques to troubleshoot analytical problems
- Recommends changes and requests investigations where required.
- Any deviations to procedures or systems are brought to the Management’s attention with logic, data and corrective measures
- Knowledge of Pharmaceutical Manufacturing and Packaging would be an asset
Working conditions
- Ability to work under stressful conditions and changing priorities
- Ability to support work in other shifts
- Numerous and varied responsibilities demanding attention and detail
- Working in general office and laboratory environments
Physical Requirements
Office based
Direct reports
NA