Analyst, Quality Control Development
Brampton, OntarioJob purpose
The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.
Duties and responsibilities
- Perform Assay and Related Substances method development and validation study using HPLC, GC and other instrumental techniques.
- Ensure timely completion of routine analysis for bulk, finished products, exhibit batches, and stability samples.
- Prepare protocol, test method and report related with method validation and method transfer studies.
- Conduct method verification, compendial update & method transfer activities.
- Identify and implement key process improvements to enhance systems, improve efficiency, and meet GMP requirements.
- Ensure Out-of-Specification (OOS), Out-of-Trend (OOT), and Corrective and Preventive Actions (CAPAs) are completed within defined timelines.
- Collaborate cross-functionally to proactively build quality into processes and systems.
- Create and revise Quality Control (QC) procedures as required.
- Provide support during internal and regulatory Inspections.
- Generate, compile and analyze data for reporting purposes.
- Complete all GMP documentation correctly and in a timely manner.
- Initiate and follow through on actions required to close change controls.
- Participate in Internal, customer and regulatory audits.
- Maintain a clean and safe laboratory environment, adhering to all safety regulations.
- Complete all assigned training and maintain up-to-date personal training records.
- Demonstrate flexibility to work shift schedules as required.
- Support peer review of analytical data.
- Contribute to new product launches.
- Perform other duties as assigned by the 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 a related discipline (minimum requirement).
- 5-7 year of experience in Assay & Impurities method validation in a pharmaceutical laboratory.
- Expert knowledge of analytical chemistry and instrumentation.
- Proficiency in analytical techniques such as UV-Vis, IR, HPLC and GC.
- Familiarity with software systems including LIMS, Empower, and Microsoft Office.
- Strong understanding and application of Health Canada and FDA regulations.
- Excellent written communication and report writing skills.
- Advanced troubleshooting and investigative skills for analytical issues.
- Ability to recommend changes and initiate investigations when necessary.
- Recommends changes and requests investigations where required.
- Knowledge of In-Vitro & Cleaning validation study is considered 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
À propos de nous
Au cours des vingt dernières années, Sun Pharma s'est affirmée comme un acteur majeur du marché des génériques aux États-Unis. Nous sommes la huitième plus grande entreprise pharmaceutique de génériques aux États-Unis et nous augmentons rapidement notre présence sur le marché des spécialités de marque, avec la dermatologie, l'ophtalmologie et l'oncologie comme segments cibles clés.
Nos valeurs
Sunology, une combinaison de Sun et d’idéologie, est le mode de vie chez Sun Pharma. Nous pratiquons l’humilité, l’intégrité, la passion et l’innovation.
Comment nous travaillons
Avec les gens au cœur de notre mission, Sun Pharma a créé une culture de travail inclusive et collaborative, où tous les employés sont encouragés à poursuivre leurs rêves et leurs aspirations professionnelles.
Create Your Own Sunshine
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Create Your Own Sunshine
At Sun we empower our employees to be Better Everyday, Take Charge and Thrive Together.
Avantages
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Santé et bien-être
Nous offrons des avantages complets, y compris une couverture médicale, dentaire et visuelle, ainsi que des programmes de santé et bien-être.
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Financier
Nous offrons un programme de contrepartie 401(k) compétitif ainsi que des programmes de bien-être financier pour soutenir les objectifs financiers à court et à long terme de nos employés.
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Vie, travail et famille
Nous offrons des avantages liés à la vie professionnelle qui soutiennent nos employés au-delà de leur journée de travail.
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À propos de nous En apprendre davantage
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Secteurs d’emploi En apprendre davantage
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