Job Description

Are you looking to make a difference in a patient\xe2\x80\x99s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

PRIMARY DUTIES AND RESPONSIBILITIES:

Management of Stability Program: obtain and review stability studies, confirms product expiry terms based on data analyses and confirm stability of product on the market

Management of the Annual Product Quality Report Program: support the APQR program by obtaining and reviewing documents related to the products; confirm product specifications are current within the master document files, confirms all changes have been documented, compiles trend-analysis data and writes a trend-analysis report.

Management and control of changes: supports the evaluation of change requests for equipment, primary and secondary components, processes, systems and various types of documents; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation. Management of trend reporting for changes.

Validation Management: ability to lead and manage Commissioning/Validation/Re-qualification projects for 3 sites and to ensure quality and compliance with regulatory requirements

Maintenance of Licenses: Initiate documentation required for Health Canada license applications/ amendments/ renewals and timely completion of quality and regulatory documents to support regulatory compliance. Maintain a tracking system for applicable Health Canada license requirements and ensuring that all Innomar Strategies Inc. licenses are up-to-date and that required renewals/amendments are submitted to Health Canada in a timely manner.

Master Document Files: Coordinate with clients and/or foreign sites in the compilation of complete GMP Quality documents to support the importation of assigned products. Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to, manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, stability reports and other product release documents. Maintain and review in-house and client-based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports, product label, temperature study etc. to support release to the market.

Management of Quality Agreements: Development and Maintenance of client Quality Agreements and internal procedures to support the agreements.

Training Management: Implement GMP Training Program and maintain training records for new and current associates, including GMP training, Innomar Strategies Inc. SOPs, Client SOPs, and Corporate Security and Regulatory Affairs (CSRA) Policies as applicable.

Preventive Maintenance and Pest Control Management: provide quality compliance oversight and support to ensure a compliant Preventive maintenance, EM and pest control program

Deviation Management: provide quality compliance oversight and support associated with nonconformance and incident reporting ensure product disposition decisions in conjunction with client and Health Canada requirements.

Customer complaints Management: provide compliance support to tracking customer complaints; works with client to identify trends and tendencies with respect to lot, product, type of complaint and determines the cause, trend analyses and drafts complaint letter to customer as appropriate. Implement and manage an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.

Controlled Drug/Narcotics Handling: support the site\xe2\x80\x99s controlled substance handling, inventory, destruction and compliance activities.

Involved in activities geared towards procedural improvements: Support the QA department in ensuring Innomar Strategies Inc. GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations at all times which may include review and approval of product-quality failure and non-compliance investigations; performs follow-up on corrective and preventive actions pursuant to an incident; performs trend analysis on systems and processes to ensure process optimization; reviews standard operating procedures; assists with internal and external audits. Assist in the development and implementation of Quality policies and procedures to ensure that regulatory compliance is maintained or enhanced.

Product Release Management: support QA department and act as backup to approval of manufacturing and packaging master files; review of batch records for manufacturing, packaging, testing, and deviations; ensures documents are in compliance; releases or rejects lots of raw materials, packaging components, imported bulk goods intended for production, and finished products intended for retail; issues appropriate certificates; assesses product returns. Assist in product launch activities as assigned. Provide regulatory and Quality Assurance guidance and support to potential new clients as assigned. Work with other functional areas to resolve issues related to information for regulatory submissions.

Inspections: Provide support during audits/inspections by internal, client, third party or regulatory bodies.

Support Quality Organization: Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assigned.

May be required to be on standby/ on call as part of this role.

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

Bachelor\'s degree required (preferably in scientific discipline)

Minimum of 5 years\xe2\x80\x99 experience in Regulatory Affairs and/or GMP Quality Assurance

Direct consumer or pharmaceutical regulatory experience

Regulatory Affairs or Quality Assurance Certification as asset

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Must have full and complete knowledge of the Good Manufacturing Practices and applicable Health Canada regulations and guidelines (i.e., Drugs, Biologics, Medical Devices, Natural Health Products, Narcotics, etc.) as they relate to Innomar Strategies Inc. activities.

High level of organization and attention to detail.

Effective time-management and prioritization skills.

Motivated and self-starter demonstrating a solution-orientated working style.

Efficient in compiling, managing and interpreting data from various sources (e.g. from clients and their affiliates).

Team player who respects all functional levels internally and externally.

Refined strategic, collaboration and presentation skills.

Effective interpersonal, written and verbal communication skills.

Knowledge of computers to effectively utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel and Adobe Acrobat).

May involve travel (up to 20 %).

What AmerisourceBergen offers

We offer a competitive total rewards package which includes benefits and compensation. Our commitment to our eligible population of team members includes benefit programs that are comprehensive, affordable, diverse, and designed to meet the needs of our team members\xe2\x80\x99 and their families. Some of these programs include paid time off including paid parental leave, access to retirement savings vehicles, medical, dental, vision, and life insurance options, an employee stock purchase program, and other financial, health, and well-being focused benefits.

Because we take a balanced, global approach to our benefits, benefit offerings may vary by location, position, and/or business unit. Some benefits are company-paid, while others are available through team member contributions. For details visit .

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Schedule

Full time

Affiliated Companies: Affiliated Companies: Innomar Strategies

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company\xe2\x80\x99s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

AmerisourceBergen is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

COVID-19 Vaccine Policy

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen\xe2\x80\x99s policy and process to apply for an exemption/accommodation.

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

AmerisourceBergen