Quality Assurance Manager

3 weeks ago

Markham, Canada Shields Pharma Inc. Full time

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham:
**Quality Assurance Manager**

**Overall Responsibilities**:
QA Manager will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, performing data and documentation review/approval, and ensuring adherence to applicable regulatory guidelines in all aspects of operation at Shields Pharma Inc..

Duties of QA Manager shall include, but are not limited to, the following:

- Provides management and guidance to Quality Assurance department staff to ensure the department is in compliance with current Good Manufacturing Practices (cGMP) and company policies, safety and labor regulations.
- Direct, delegate assignments and review work assigned
- Prepare and/or review/approve deviations, investigations, protocols, lab data, SOPs and any other reports or documents as needed
- Provide support, direction and coaching to subordinate employees in the areas of the QA department
- Assist with preparation and participate in HPFBI/FDA or other compliance audits
- Assist with preparation and participate in client audits
- Preparation of written response to client/regulatory observations
- Give critical review and guidance for protocols and product dispositions for deviations, investigations, etc
- Give guidance and support on cGMP compliance
- Develop and provide sufficient SOP and GMP training programs
- Ensure Metrology, Computer Validation, Microbiology, and Chemistry testing programs are performed in a complete, compliant and accurate manner, and adhere to applicable regulatory guidelines
- Prioritize departmental activities in alignment with the regulations, and client/corporate goals.
- Develop and monitor effectiveness of CAPA, Change Controls, TAR/OOS Reports.
- Streamline systems as needed to conform to cGMP and company objectives
- Help develop annual budget expectations for QA department that includes but not limited to QA head count requirements to meet workload projections
- Develop metric and benchmarking reports for presentation to top management
- Present information to top management, public groups, and/or boards of directors
- Any ad-hoc tasks assigned by the Shields Pharma’s Senior Management

**Qualifications and required skills**
- Completed Bachelor of Science degree with a focus on Chemistry
- GMP and QA related experience or equivalent, a majority of which are in the area of quality assurance and compliance experience.
- Demonstrated experience in a Quality Supervisory capacity
- Experience in managing relationships with vendors and clients
- In depth knowledge of cGMPs and related Health Canada Acts, FDA, and European regulations
- In depth knowledge of cGDP and related documentation practices
- Intermediate level knowledge of MS Word, Excel and Outlook
- Demonstrated good communication and writing skills
- Strong supervisory skills including delegation, time management, work allocation and leadership

**The above positions are only applicable to Canadian citizens with a minimum degree in science and five years of direct experience.**

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 3 years (preferred)

Ability to Commute:

- Markham, ON (preferred)

Work Location: In person

Application deadline: 2023-12-10

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