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Analyst, Quality Control Development

SUN PHARMA

Brampton

On-site

CAD 60,000 - 85,000

Full time

15 days ago

Job summary

A leading pharmaceutical company seeks a Quality Control Analyst to manage method development and validation activities. You will ensure compliance with regulatory standards, conduct analytical testing, and collaborate across departments to improve processes. Ideal candidates have a Bachelor's Degree in Chemistry and several years of relevant laboratory experience.

Qualifications

  • 3-5 years of method validation, verification & transfer experience in a pharmaceutical laboratory.
  • Demonstrated technical writing and report writing skills.
  • Expertise with analytical instrumentation and understanding of FDA regulations.

Responsibilities

  • Perform method development, validation, and transfer activities.
  • Ensure timely completion of routine analysis for Bulk and Finished Products.
  • Participate in process improvement projects and support compliance during audits.

Skills

Analytical Chemistry
Interpersonal Skills
Problem Solving
Teamwork
Organizational Skills

Education

Bachelor’s Degree in Chemistry

Tools

HPLC
GC
LIMS
Empower
MS Office

Job description

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
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