Compliance & Regulatory Specialist

PNP Pharmaceuticals is seeking a Compliance & Regulatory Specialist to join our team!

PNP Pharmaceuticals, established in 1999, has rapidly grown to become one of Canada’s most respected and reliable contract manufacturers of nutraceuticals and pharmaceuticals.

We provide unique and innovative formulations to our client’s specifications. Today, PNP Pharmaceuticals manufactures high quality nutraceutical and OTC products for markets worldwide.

We are looking for the ideal candidate for the new position of Compliance & Regulatory Specialist at PNP. We are currently in an exciting phase of development and growth throughout our organization.

This is a great opportunity for a talented professional to help us further unlock PNP’s potential, while continuing to unlock their own.

As a member of our team, you will be a part of a fast-paced, dynamic, and constantly evolving environment of passionate individuals who aim to be an industry leader.

If you see yourself playing a pivotal role in shaping the success narrative of PNP, this is a position for you! Join us on our journey of innovation and drive to make meaningful change within PNP and beyond.

Shift

Monday to Friday 9 : 00 to 17 : 00

Work Location

On-site

Duties and Responsibilities

Primary

1. Oversee the development and maintenance of an integrated Quality Management System (QMS) that is compliant with GMP requirements from major regulatory bodies including Health Canada, US Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA).

2. Prepare and present quarterly management meetings to update management on KPIs for department.

3. Ensure Company is continuously complying with all third-party certifications including the National Science Foundation (NSF) for Dietary Supplements / Sports, Informed Choice, Organic, Kosher, Halal and Non-GMO, and Brand Reputation through Compliance Global Standard (BRCGS).

4. Coordinate export applications on behalf of Partners, including advising and submitting.

5. Verify and approve production labels according to applicable regulations.

6. Responsible for supplier qualifications in a timely manner, ensuring documents are up to date.

7. Initiate, prepare, review, and evaluate responses to the customer complaints for all manufactured products, and coordinate all investigation activities with internal departments.

8. Maintain accurate and updated records of all approved documents, Master Documents, and logs ensuring only latest approved documents are used.

9. Provide document control support, including issuance of controlled documents, document tracking, and processing, including the Change Control program.

10. Assist in investigations for Out Of Specifications (OOS) and reported deviations.

11. Execute Corrective Action, Preventive Action (CAPA) procedures including facilitating identification of root causes, risk assessment, and implement corrective actions ensuring effectiveness through monitoring.

12. Create and revise SOPs ensuring alignment with Company procedures and external regulations.

13. Audit internal facilities and systems for compliance to SOPs, GMP regulations and other applicable regulations.

14. Support all Quality Assurance Systems as needed.

15. Calibrate testing instruments (i.e. scales, hygrometer).

16. Conduct self-inspection to meet Health Canada GMP requirements for Drug manufacturing.

17. Review & evaluate the Annual Product Quality Reports (APQR) for drug product lines.

18. Assist in preparing for external audits and act as backup to Compliance and Regulatory Manager if needed.

19. Stay abreast of regulatory changes and report to management as needed.

20. Act as Compliance and Regulatory Manager during vacations and other absences.

21. Participate and provide suggestions for the development and continuous improvement of all departmental processes.

Additional

1. Participate in and further the Company’s health & safety program.

2. Report equipment malfunctions immediately.

3. Report quality deficiencies immediately.

4. Offer suggestions for process improvement.

5. Other related duties.

6. Participate in planning of department objectives and oversees teamwork efforts to meet goals, project timelines and deliverables.

Qualifications

Knowledge

1. Fluent in verbal and written English.

2. Bachelor’s degree in science or related field equivalent to Canadian or US Institution.

3. HACCP certified.

4. 2 years’ experience working for Canadian or US company in a similar or related field.

Assets

5. Familiarity with Good Manufacturing Practices (GMP).

6. PCQI certified.

Skills

1. Willingness to learn.

2. Basic proficiency using project management tools.

3. Basic proficiency in mathematics (adding, subtracting, multiplying & dividing).

4. Basic proficiency in using computers.

5. Basic proficiency in using the Microsoft Suite (Word, Excel, PowerPoint, Outlook).

6. Excellent attention to detail.

7. Strong time management.

8. Strong verbal and written communication.

9. Good external client service.

10. Good internal client service.

11. Strong influencing of both colleagues and leadership.

12.Excellent in working with people and relationship building.

Abilities

1. Lift a minimum of 10 kg.

2. Work independently on assigned duties.

3. Balance a variety of competing priorities while meeting deadlines.

Health

1. Must be in good health with no communicable diseases or dust allergies.

3. Must follow appropriate gowning procedure before going into production area.

4. Follow health & safety regulations.

We truly thank all applicants in advance for your interest in PNP Pharmaceuticals, but only shortlisted candidates will be contacted for an interview.

However, all candidates will be notified when the posting is filled.