Specialist, Deviations

4 weeks ago

Mississauga, Ontario, Canada Resilience Full time

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit

JOB SUMMARY: The Deviation Specialist (Specialist) will play an important role in the department by writing deviations, participating in Out of Specification analysis investigation, closing batch documentation prior to release and communicating with internal stakeholders/SME and client. In addition, the Specialist will act as a point of contact between the manufacturing group, QA/client QA and regulatory agencies.

MAJOR RESPONSIBILITIES:

  • Authors deviations, Investigations, Environmental Monitoring Excursion and CAPA for Manufacturing (USP/DSP/Fill/Finish Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.
  • Participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation re-occurrence.
  • Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.
  • Actively participates in regulatory, client and internal audits by compiling and providing information to department manager.
  • Ensures Deviations are closed within assigned timelines to meet client demand and company targets.
  • Participates in data gathering and analysis for Monthly and Quarterly quality matrix as well ad departmental KPI.
  • Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales.
  • Implement process improvement related changes.
  • Ensure corrective and preventative action that have been implemented are effective via Effectiveness Checks (EC) Provide support in ensuring batch readiness action items are completed prior to batch start Performs all other job-related duties as assigned

This is a fixed-term contract position for the next 18- months

MINIMUM QUALIFICATIONS:

  • Demonstrate ability to review manufacturing, engineering, and quality documentation
  • Strong working knowledge GMP requirements.
  • Experience in top-tier biopharmaceutical environment
  • Knowledge of regulatory agencies HC, FDA and others

PREFERRED QUALIFICATIONS:

  • Diploma with 3+ years of industrial experience in pharmaceutical practices or a B.Sc.
  • Demonstrate ability to perform RCA investigations and lead CAPA initiatives.
  • Experience in top-tier biopharmaceutical environment Knowledge of regulatory agencies HC, FDA and others.

BEHAVIOURAL:

  • Demonstrate ability to apply the following behavioural competencies on the job
  • Teamwork: Working effectively and productively with others
  • Independence: Ability to work with minimal supervision
  • Flexibility: Agility in adapting to change
  • Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.
  • Problem Solving: Anticipating, analyzing, diagnosing and resolving problems
  • Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
  • Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
  • Diligence: Attention to detail.

This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization. While we appreciate your interest in this opportunity, only qualified candidates will be contacted.

Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team. NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted). Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $24.00 - $33.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

  • Pharmacovigilance Specialist

    6 days ago

    Mississauga, Ontario, Canada Shoppers Drug Mart Specialty Health Network Full time

    About the RoleThe Pharmacovigilance Specialist is responsible for identifying, reviewing, and submitting adverse events, product complaints, as well as other pharmaceutical safety information received from patients, clinics, internal customers, and healthcare professionals to various pharmaceutical companies supported within specific required timeframes.This...

  • Pharmacovigilance Specialist

    12 hours ago

    Mississauga, Ontario, Canada McKesson Full time

    Job SummaryThe Bilingual Pharmacovigilance Specialist will play a critical role in ensuring the accuracy and completeness of adverse event data. This position requires a detail-oriented individual who can work independently and collaboratively as part of a team.The ideal candidate will have experience in pharmacovigilance activities and be proficient in...

  • Adverse Event Specialist

    5 days ago

    Mississauga, Ontario, Canada McKesson Full time

    Overview:Mckesson is committed to making a real difference in the lives of those we serve. Our pharmacovigilance team plays a crucial role in ensuring the safety and efficacy of medications, and we are seeking a skilled Bilingual Pharmacovigilance (PV) Specialist to join our team.Responsibilities:- The successful candidate will be responsible for...

  • Pharmacovigilance Specialist

    2 days ago

    Mississauga, Ontario, Canada MCD McKesson Canada Corporation La Corporation McKesson Canada Full time

    Job Description Job Summary The Bilingual Pharmacovigilance (PV) Specialist is an integral part of the pharmacovigilance team, and is responsible for the identification, collection, documentation, processing and reporting of adverse event data in compliance with Health Canada regulations and client specific requirements. The Bilingual PV Specialist will...

  • Welder – Fabrication Specialist

    7 days ago

    Mississauga, Ontario, Canada Can-Am Geomatics Corp. Full time

    About the Role:We are seeking an experienced Welder to join our team as a Fabrication Specialist. As a key member of our fabrication team, you will be responsible for ensuring that all fabricated products meet our high standards of quality and safety.Key Responsibilities:Inspect all fabricated products to ensure they meet our quality standardsPerform visual...

  • Lead Consultant

    2 weeks ago

    Mississauga, Ontario, Canada Q&C Services Full time

    1 week ago Be among the first 25 applicantsDirect message the job poster from Q&C ServicesRecruitment Specialist @ Q&C Services | Pharma ConsultingThis pharmaceutical consultant role focuses on applying your GMP knowledge and experience to various projects, ensuring the client is confident in the approach and timing of execution of the project. Our...

  • Only 24h Left FSQA Specialist

    4 weeks ago

    Mississauga, Ontario, Canada Maple Leaf Foods Full time

    The Opportunity:As a member of the FSQA team, the FSQA Specialist is accountable for the execution of the HACCP system, Food Safety and Quality Assurance programs. The FSQA Specialist is a key member of the facility management teams and is responsible for driving continuous improvement in a fast-paced and demanding environment. Additionally, the FSQA...

  • Automation and Controls Specialist

    7 days ago

    Mississauga, Ontario, Canada Unisync Group Limited Full time

    Job SummaryWe are seeking a highly skilled Automation and Controls Specialist to join our team. In this role, you will be responsible for planning and overseeing the implementation of systems and technical services projects.Key ResponsibilitiesTroubleshoot and respond to equipment and software problems.Review, design, and implement site automation strategy...

  • Specialist I, Technical Services

    4 weeks ago

    Mississauga, Ontario, Canada Resilience Full time

    A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach...

  • Financial Optimization and Compliance Specialist

    5 days ago

    Mississauga, Ontario, Canada Cargojet Full time

    Key ResponsibilitiesEvaluate key business expenditures to identify cost-saving opportunities and avenues for renegotiating vendor contracts.Develop and maintain financial models and analytical tools to support decision-making and track performance.Monitor compliance with contractual obligations and report deviations or opportunities for improvement.Evaluate...

  • Specialist, Connected Business

    2 days ago

    Mississauga, Ontario, Canada Subaru Canada Inc Full time

    Specialist, Connected Business ul.align_lines { list-style: none important; padding: 0; display: table; line-height: 1.7; margin-bottom: 15px;} ul.align_lines li { padding-left: 16px; display: table-row; } ul.align_lines li::before { content: "•"; /* Insert content that looks like bullets */ padding-right: 8px; color: inherit; /* Or a color you...

  • Multilingual Pharmacovigilance Coordinator

    15 hours ago

    Mississauga, Ontario, Canada McKesson Full time

    Company OverviewMckesson, a leading Fortune 10 company, plays a vital role in the healthcare industry. Our mission is to improve patient care by providing innovative solutions and services that make quality healthcare more accessible and affordable.We are committed to fostering a culture where our employees can grow, make an impact, and thrive. Our team is...

  • Bilingual Patient Services Specialist

    2 days ago

    Mississauga, Ontario, Canada MCD McKesson Canada Corporation La Corporation McKesson Canada Full time

    The Patient Services Specialist is an integral part of the Patient Services team, responsible for providing administrative & patient counseling support to physician offices primarily to assist with the completion of paperwork and follow up on the submissions pertaining to obtaining drug reimbursement through private and provincial drug plans, relating to...

  • Quality Control Specialist FSQA

    6 days ago

    Mississauga, Ontario, Canada Maple Leaf Foods Inc. Full time

    Job Summary:The FSQA Coordinator is accountable for ensuring day-to-day FSQA processes and procedures are followed. This involves leading cross-functional teams to ensure compliance with Food Safety programs and requirements.About Us:We are a global food company dedicated to making delicious, healthy protein that Canadians love under iconic national and...

  • Senior Automation Engineer

    6 days ago

    Mississauga, Ontario, Canada KUKA Full time

    Job SummaryThe Senior Application Engineer at KUKA will be responsible for providing technical support to our customers, developing and maintaining internal programs, and managing project timelines.Key ResponsibilitiesDevelop and maintain internal programs from inception through completion.Manage project timelines and inform department managers of project...

  • Bilingual Pharmacovigilance Specialist

    2 weeks ago

    Mississauga, Ontario, Canada McKesson Full time

    McKesson, l'une des 10 premières entreprises du classement Fortune Global 500, touche à pratiquement tous les aspects des soins de santé et s'emploie à faire une réelle différence. Nous sommes reconnus pour notre capacité à offrir un savoir, des produits et des services qui rendent les soins de qualité plus accessibles et plus abordables. Chez nous,...

  • Validation Engineering Specialist III

    2 days ago

    Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

    Provide specialized validation knowledge and information, which is directly required to support operations and clients. Finish the protocols related to the validation of equipment andfacilities processes and review all finished reports prior to final approval. Ensure documents conform to all SOPs, client requirements and Good Manufacturing Practices. What...

  • Advanced Manufacturing Specialist

    2 hours ago

    Mississauga, Ontario, Canada Pirlitor Machine & Tool Ltd. Full time

    About Pirlitor Machine & Tool Ltd.:We are a leading manufacturer of precision machined parts and prototype components.We are dedicated to delivering high-quality products and providing excellent customer service.Job Requirements:We are seeking an experienced 5-axis CNC Expert Machinist to join our team. The successful candidate will be responsible for...

  • 5-Axis Machining Specialist

    5 days ago

    Mississauga, Ontario, Canada Pirlitor Machine & Tool Ltd. Full time

    About UsPirlitor Machine & Tool Ltd. is a leading manufacturer of precision machined parts and components. Our company operates under the principles of quality, integrity and customer satisfaction.Job Description:The successful candidate will be responsible for setting up, operating, adjusting and maintaining 5-axis machines and tools to perform...

  • Senior Client Service Specialist

    2 days ago

    Mississauga, Ontario, Canada CA003 Victor Insurance Managers Inc (CA) Full time

    Description: We are seeking a talented individual to join our team at Victor. This role will be based in Mississauga, Canada. This is a hybrid role that has a requirement of working at least three days a week in the office. This Sr. Client Service Specialist position helps review, research, and respond (via phone or e-mail) to unique and non-routine...