Auditeur de conformité I/II/III / Compliance Auditor I/II/III

Jubilant Pharma, LLC; Montreal; On-site; CAD 60,000 - 100,000; Full time

Job summary

Join an innovative and fast-growing company as a Compliance Auditor I/II/III, where you will play a crucial role in ensuring adherence to regulatory standards in the pharmaceutical industry. This position offers a unique opportunity to work with a dedicated team, conducting audits and supporting quality compliance efforts. You will engage with various departments, lead audits, and contribute to the continuous improvement of processes and systems. With a culture that values professional growth, this role promises a rewarding challenge in a dynamic environment focused on excellence and compliance. If you are passionate about quality assurance and regulatory standards, this is the perfect opportunity for you.

Benefits

Comprehensive Medical Insurance

Dental Insurance

Disability Insurance

Retirement Savings Program

Health and Wellness Programs

Qualifications

• Bachelor's degree in a related field or equivalent experience required.
• 2-10 years of experience in a pharmaceutical or FDA-regulated environment needed.

Responsibilities

• Conduct internal and supplier audits to ensure compliance with GMP regulations.
• Manage the Internal Audit and Supplier Audit Programs effectively.

Skills

Quality Systems Knowledge

Regulatory Compliance

Aseptic Pharmaceutical Manufacturing

Internal Audits

Supplier Audits

Document Inspection

Education

Bachelor’s Degree in Life Sciences

Certified Quality Auditor Certification

Tools

Microsoft Office (Word, Excel, PowerPoint)

SAP

TrackWise

Job description

JOB DESCRIPTION

Compliance Auditor I/II/III

Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc. is currently recruiting for a Compliance Auditor I/II/III to join our team!

What do we offer?

A culture that values opportunities for professional growth and development, a highly competitive base salary, comprehensive medical, dental and disability insurance programs, a group retirement savings program, health and wellness programs. Jubilant HollisterStier is a fast-growing company with offices in Kirkland, Quebec, and Spokane, Washington. As an integrated contract pharmaceutical manufacturer, Jubilant HollisterStier Subcontracting & Services has the capacity to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India offer specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. For more information, visit www.jublhs.com.

We will continue, with the utmost care for the environment and society, to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, profitability and wise investment of resources. If you're ready for a rewarding challenge, we invite you to take the first step and apply today!

Purpose of the Job

The Compliance Auditor I/II/III is a highly visible operational position of the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company is adhering to all cGMPs, including Health Canada, FDA, EU and other applicable International Regulations, Guidance documents and Standards via performance of internal audits. The incumbent manages the Internal Audit and Supplier Audit Programs for GMP, GDP and GLP compliance, working closely with the operational functions to define and review processes, procedures, and systems to be audited annually. Essential duties include but are not limited to:

1. Ensures that JHS meets regulatory agencies expectations and customers' needs by auditing / monitoring key suppliers that provide material or services utilized for executing GMP activities. The Compliance Auditor accomplishes this by performing audits / monitoring in order to assess compliance to current GMP regulations, Jubilant policies, directives and procedures.
2. Responsible for the development, maintenance and execution of the Internal and Supplier audit program and conducting GXP audits in accordance with the audit schedule including but not limited to:
1. Creates and executes a systematic approach to conduct all audits presenting findings and recommended changes to procedures or practices that are not in compliance with stated regulations.
2. Manages and maintains the Internal Audit and Supplier qualification programs, including associated Audit schedules, SOP’s, Approved Supplier List (TrackWise PR records), and Supplier Quality Agreements, etc.
3. Planning the scope and scheduling audit(s) with internal departments, and suppliers by creating an audit plan and identifying resources within Jubilant to assist with the audit, when applicable.
4. Issue audit observations and reports as per the required deadlines requiring minimal edits from the approver.
5. Reviews and evaluates Internal and Supplier audit responses to determine acceptability of the response and any applicable CAPA plans. Performs follow up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal and supplier audits in the approved audit tracking system.
6. Leads for-cause audits as required to address suspected critical audit findings, fraud, or misconduct related to suppliers, or internal processes etc.
7. Reporting metrics to Site, Department and Corporate Quality management.
3. Supports readiness of the facility for Regulatory Inspection. Assists site operations during regulatory and third party inspections, and serves as co-host when required as well as participating in associated tasks.
4. Completes department related Change Controls, CAPAs and Deviations as required.
5. Works cross functionally on improvement projects related to audit compliance, supplier qualification and other quality-related subjects within the organization.
6. Review and approve component specifications and SAP source lists.
7. Support compliance efforts and represents QA on projects related to new suppliers or materials.

Qualifications:

Auditor I:

• Bachelor’s degree in related professional technical or life sciences degree/field or equivalent combined education and experience.
• Minimum of two (2) years of experience within a Pharmaceutical or FDA-regulated environment required.
• Experience with aseptic pharmaceutical manufacturing experience is desired.
• Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits.
• Experience with regulatory authorities and/or regulatory inspections desired.
• This position requires knowledge of regulations such as Health Canada, FDA, EU, ISO and other applicable guidance documents. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in documents, products and processes. Proficiency using Microsoft Word and Excel required.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.

Auditor II:

• Bachelor’s degree in related professional technical or life sciences degree/field or equivalent combined education and experience.
• Minimum five (5) years of related experience, must include Quality Unit experience.
• Minimum of two (2) years of experience within a Pharmaceutical or FDA-regulated environment including experience with aseptic pharmaceutical manufacturing.
• Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits.
• Experience with regulatory authorities and/or regulatory inspections desired.
• This position requires knowledge of regulations such as Health Canada, FDA, EU, ISO and other applicable guidance documents. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in documents, products and processes. Proficiency using Microsoft Word and Excel required.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.

Auditor III:

• Bachelor’s degree in related professional technical or life sciences degree/field or equivalent combined education and experience.
• Certified Quality Auditor or equivalent certification required.
• Minimum ten (10) years of related experience, must include Quality Unit experience.
• Minimum of five (5) years of experience within a Pharmaceutical or FDA-regulated environment including experience with aseptic pharmaceutical manufacturing.
• Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits.
• Experience with regulatory authorities and/or regulatory inspections desired.
• This position requires knowledge of regulations such as Health Canada, FDA, EU, ISO and other applicable guidance documents. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in documents, products and processes. Proficiency using Microsoft Word and Excel required.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.