Job title:
Analyst, Quality Control Development
Company
Sun Pharmaceutical Industries
Job description
Job purposeThe 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 dayQualifications
- 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 requirementsOffice basedDirect reportsNA
Expected salary
Location
Brampton, ON
Job date
Fri, 18 Jul 2025 05:56:55 GMT
To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnearcanada.com) you saw this job posting.