25 meilleures offres (implementation lead, kelowna, bc) (à pourvoir)

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Culinary Arts Vocational Instructor
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Senior Programmer - Analyst, Learning Systems
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Pivot Point Family Growth Centre Inc. —Vernon, BC
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Bulk Pkg Team 1 - Bulk Packager
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Bulk Packaging Operator T3
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Activity Program Leader - School Aged Programs (South Okanagan)
YMCA of Southern Interior BC —Penticton, BC
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Manager - Business Development Services
Wesco —Kelowna, BC
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Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : implementation lead (kelowna, bc)

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GMP Specialist

The Flowr Group (Okanagan) Inc.
Kelowna, BC

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Détails du poste

Temps plein
Il y a 9 jours

Avantages

Assurance Maladie Complémentaire
Assurance Dentaire
Vacances payées

Compétences

Esprit d'analyse
Gestion de projet
Baccalauréat
Gestion des risques
Pharmacie
Chimie
Production
Compétences en communication

Description complète du poste

Avant is an innovative, market-leading premium cannabis company. Avant has multiple operational production facilities across Canada, which produce high-quality, handcrafted cannabis products, based on unique and exceptional cultivars. Avant is a publicly traded corporation listed on the Toronto Stock Exchange (TSX: AVNT), and cross-trades on the OTCQX Best Market (OTCQX: AVTBF) and Frankfurt Stock Exchange (FRA: 1BU0). The Company is headquartered in Kelowna, British Columbia and has operations in British Columbia, and Ontario.

The Flowr Group (Okanagan) Inc. is an 80,000 sq.ft. cannabis cultivation facility based in Kelowna/Lake Country, British Columbia. The Flowr Group (Okanagan) Inc. is a subsidiary of Avant Brands K1, which is a wholly owned subsidiary of Avant Brands (and GreenTec Holdings Ltd.).

The Flowr Group (Okanagan) Inc. is hiring for a GMP Specialist to join the Quality Department.

Position Summary
We are seeking a highly experienced GMP professional with a strong background in pharmaceutical, cannabis, biotechnology, natural health products, or regulated manufacturing environments. The successful candidate will play a key role in supporting EU GMP readiness, regulatory compliance, quality systems development, validation activities, external and internal audits, supplier qualification, and inspection preparedness.

This is a hands-on role requiring a strong understanding of GMP regulations and the ability to work collaboratively across Quality, Production, Maintenance, Supply Chain, and Sales/Marketing departments.

Key Responsibilities

Validation & Qualification

Lead the development, execution, review, and approval of validation and qualification activities.
Author and review:
Validation Master Plans
Process Validation Protocols and Reports
Equipment Qualification (IQ/OQ/PQ)
Facility Qualification
Cleaning Validation
Computerized System Validation
Environmental Monitoring Qualification
Temperature Mapping Studies
Utilities Qualification
Perform risk assessments to support validation activities.
Ensure validation programs remain compliant with EU GMP, PIC/S, and Health Canada requirements.
Support lifecycle management of validated systems.

Quality Management Systems

Develop, review, and maintain GMP-compliant quality system procedures and records.
Support implementation, maintenance, and continuous improvement of GACP, GPP, and EU GMP quality systems.
Support change management initiatives through the development, review, revision, and implementation of SOPs, forms, protocols, reports, specifications, and other controlled documents.
Perform quality and regulatory impact assessments associated with proposed changes and support implementation activities.
Support quality risk management activities and investigations.

Deviations, Investigations, and CAPA

Lead and support deviations and investigations.
Conduct root cause analysis using appropriate methodologies.
Develop and implement corrective and preventive actions (CAPAs).
Verify CAPA effectiveness and support continuous improvement initiatives.
Assess product impact and recommend disposition actions when required.

Supplier Quality Management

Conduct supplier qualification, risk assessments, and ongoing supplier performance evaluations.
Evaluate suppliers against applicable GACP, GPP, GMP, regulatory, and company requirements.
Review supplier questionnaires, quality documentation, certifications, and supporting records.
Plan, conduct, and document external supplier audits, including on-site and remote assessments as required.
Support the development, review, and maintenance of quality agreements.
Lead supplier remediation activities, including management of audit observations, corrective actions, and effectiveness verification.
Maintain Approved Supplier Lists and supplier monitoring programs.

Regulatory Compliance and Inspection Readiness

Maintain knowledge of:
EU GMP (EudraLex Volume 4)
PIC/S GMP Guide
Good Agricultural and Collection Practices (GACP)
Cannabis Regulations
ICH Quality Guidelines (ICH Q9 and Q10)
Participate in internal audits and mock inspections.
Support Health Canada, EU GMP, customer, and third-party audits.
Assist with regulatory responses and inspection observations.

Product Quality and Quality Oversight

Support Product Quality Reviews (PQRs).
Review quality metrics and trend analyses.
Participate in quality review meetings.
Support batch record review and quality documentation assessments.

Qualifications

Required Education

Bachelor's Degree in:
Pharmacy
Chemistry
Microbiology
Biochemistry
Biotechnology
Engineering
Life Sciences
Related Scientific Discipline

Required Experience

Minimum 7–10 years of GMP experience in a regulated industry.
Minimum 3 years of direct experience with pharmaceutical or EU GMP systems.
Minimum 3 years of validation and qualification experience, including authoring and executing IQ/OQ/PQ protocols.
Demonstrated experience developing, implementing, and maintaining GMP quality systems.
Experience leading deviations, investigations, CAPAs, change controls, and quality risk assessments.
Experience preparing for and supporting regulatory inspections, certification audits, and customer audits.
Strong technical writing experience, including SOPs, validation protocols, validation reports, risk assessments, and quality investigations.

Strongly Preferred

Experience obtaining, maintaining, or supporting EU GMP certification.
Experience in pharmaceutical manufacturing.
Experience in cannabis manufacturing or cultivation.
Experience with sterile or non-sterile pharmaceutical operations.
Experience leading internal, supplier, customer, and regulatory audits.
Experience performing supplier qualification and supplier audits.
Experience with Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).
Lead Auditor certification (ISO 9001, GMP, or equivalent).

Knowledge and Skills

The ideal candidate will possess:

Expert knowledge of EU GMP requirements, including EudraLex Volume 4 and PIC/S GMP guidance.
Strong knowledge of GACP principles and their application within cannabis cultivation and post-harvest operations.
Thorough understanding of validation lifecycle principles and qualification programs.
Strong understanding of Quality Risk Management principles.
Exceptional technical writing and documentation skills.
Excellent organizational and project management abilities.
Strong analytical, investigative, and problem-solving skills.
Ability to influence and collaborate across multiple departments.
Ability to independently manage multiple projects and priorities in a fast-paced regulated environment.
Strong communication and audit-hosting skills.

Compensation

The Flowr Group offers a competitive compensation package commensurate with experience and qualifications, including:

Competitive salary
Extended health and dental benefits
Paid vacation
Opportunity to play a key role in an expanding EU GMP export program

How to Apply

Interested candidates should submit:

Resume/CV
Cover Letter
Relevant certifications and qualifications

Only candidates selected for an interview will be contacted.

Job Type: Full-time

Pay: $70,000.00-$100,000.00 per year

Benefits:

Dental care
Extended health care

Flexible language requirement:

French not required

Application question(s):

How many years of experience do you have working within GMP-regulated environments?
Please describe your experience with EU GMP, pharmaceutical GMP, or PIC/S GMP systems.
What validation and qualification activities have you led or supported (e.g., IQ/OQ/PQ, process validation, cleaning validation, CSV, facility qualification)?
Have you conducted supplier audits? If yes, please describe the types of suppliers audited and your role in the audit process.
Are you located in the Okanagan region or willing to relocate to Lake Country, BC?

Work Location: In person

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