Senior Analyst, Quality Control

2 months ago

Brampton, Canada Sun Pharmaceutical Industries, Inc. Full time

Job purpose

The main responsibility for this position is to lead activities towards the maintenance of a site-wide quality program to meet Taro, Canadian, and FDA cGMP requirements. This position acts as an active influence towards elevating the quality practices and guidelines for the product manufactured, packaged, or tested at the Taro manufacturing facility.

This position may focus on either:

  • the coordination of activities for a designated team ensuring the highest possible quality of work and schedule attainment (Team Leader) or,
  • project leadership of method development, validation, and transfer activities to support Quality Control and Operations (Development).

Duties and responsibilities

Team Leader focus:

  • Lead a team of analysts to conduct GMP laboratory testing, providing coaching, Subject-Matter-Expertise, and technical mentorship
  • Leads in the rollout of new laboratory requirements, business operation/processes, and technologies to the analyst team
  • Provide troubleshooting of test method and equipment issues
  • Responsible for the full-cycle of internal lab investigations including trending and preventative actions
  • Technical training of Analyst in analytical methods as well as on-boarding of new employees
  • In-process, bulk, FG, Stability, validation / verification, and investigation sample testing
  • Method transfer activities
  • With the Quality Control Supervisor, lead meetings to determine priorities, coordinate the workload and communicate and seek agreement with the team on group priorities
  • Provide support for internal and regulatory inspections
  • Recommend, design, and deliver training targeted to ensuring the technical capability of the team as well as compliance with SOPs & Canadian and FDA cGMP and HS&E requirements
  • Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements
  • Other duties as assigned

Development focus:

  • Leads the Development and Validation of methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods
  • Development and validation of cleaning validation methods as required
  • IV Drug release testing for product comparison
  • Process Validation and Cleaning Validation testing
  • Method Transfer activities
  • New Product introduction
  • Product, Method, and Raw Material troubleshooting
  • Lead projects in the area of focus related to process improvement
  • With the Quality Control Supervisor, leads meetings to determine priorities, coordinate the workload and communicate and seek agreement with the team on group priorities
  • Act as Subject Matter Expert and provide technical assistance, coaching, and guidance to the team
  • Create job rotation schedule and provide cross-training for QC Analysts to ensure the proficiency of staff in all QC programs
  • Collaborate with other departments to proactively build quality into the processes and systems
  • Creation and revisions to QC procedures as required
  • Provide support for internal and Regulatory Inspections
  • Recommend, design, and deliver training targeted to ensuring the technical capability of the team as well as compliance with SOPs & Canadian and FDA cGMP and Health, Safety, and Environmental requirements
  • Identifies and implements key process improvements to areas 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
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non-Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer, and Regulatory Audits
  • Other duties as assigned

Knowledge, Skills, and Abilities:

  • 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 the achievement of shared goals
  • Excellent written communication and report writing skills
  • Strong organizational skills and ability to multi-task; detail-oriented
  • Excellent problem-solving and judgment
  • Advanced ability in investigative techniques to troubleshoot analytical problems
  • Demonstrated ability to coach, mentor, and lead
  • Ability to work effectively in a team-based environment
  • Proficiency with applicable software (LIMs and Empower)

Problem Solving:

  • Acting Senior Quality individual requires the execution of judgment, as well as understanding of when escalation is appropriate
  • 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
  • Implement short-range strategies and objectives towards enhancing the quality standards of the department and facility
  • Non-routine problems and decisions involving method changes, product issues, and equipment issues

Qualifications

  • Bachelor’s Degree in Chemistry or related discipline
  • 5-7 years experience in the pharmaceutical industry in a Quality Control Laboratory
  • Knowledge of Pharmaceutical Manufacturing and Packaging an asset
  • Demonstrated technical writing skills
  • Well-developed interpersonal and teamwork skills
  • Demonstrated leadership skills including coaching and training

Working conditions

  • Generally, fairly pleasant surroundings. Occasional exposure to higher than normal noise levels, frequent exposure to various chemicals used in the testing of finished products. Occasional exposure to unpleasant odors resulting from testing procedures. Fairly level temperatures.
  • 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

Mixture of standing and walking, some light lifting and/or moving of instruments with the aid of a cart.

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