QA/QC Manager, Moncton, NB

The QA/QC Manager, based in Moncton is responsible to insure that manufacturing processes comply with regulations and standards. In the event of a failure to comply with required standards, QA/QC Manager will lead the investigations, and follow up on the CAPA implementation. In addition, the QA/QC Manager is also responsible for the management of documentation, change control and training for employees.
The QA/QC Manager reports to the Senior VP Pharmaceutical Compliance and Quality.

DUTIES AND RESPONSIBILITIES:
o Oversee the quality management system to ensure the company’s compliance with cGMPs.
o QA Manager needs to keep updated on good industry practices and to ensure the system adjusts to changes in requirements.
• To Audit Compliance to the Quality System
o Audit policies and procedures to ensure compliance in documents and in practice.
o Report on the performance of the quality system, including trends that help decision-making for targeted actions.
• To Establish Procedures and Specifications
o Ensure that SOPs and specifications are created and followed.
o Ensure that third-party services providers (contract manufactures, contract laboratories, etc.) follow the same guidelines and conform to requirements.
• To Establish Manufacturing Controls
o To implement appropriate manufacturing in-process controls.
o Ensure in-process controls are performed during manufacturing operations and results are satisfactory.
• To Review/Approve/Reject cGMP Related Activities
o Review, /approve/reject any document that gives work instructions and set requirements such as procedures, protocols test methods and specifications – including changes to these documents.
o Review/approve/reject reprocessing and rework procedures as per company policy.
o Manufacturing documentation: review and approve/reject production batch records and make the final decision to release a product lot into the market.
• To Ensure Investigation of Non-Conformances
o Ensure investigation is conducted and root cause(s) are identified and eliminated for production and control record errors, discrepancies, and failures to meet specification.
• To Keep Management Informed
o Report on product process or system risks- and keep management informed.
o Report on outcome of regulatory inspections and ensure responses are completed and managed to verifiable closure -and keep management informed.

QUALIFICATIONS and SKILLS:
• B.Sc in a relevant field
• Minimum 5 years’ work experience in a similar domain (pharmaceutical, medical device, cosmetics, biotechnology etc.)
• Management skills, ability to motivate others and to provide guidance, advice and support to employees and other professionals
• Supervisory experience is an important asset
• Excellent Interpersonal skills
• Good ability to work in a team
• Excellent time management, planning and organizational skills
• Problem-solving capabilities
• Good ability to function under pressure
• Vigilance and attention to details
• Strong written and verbal communication skills
• Knowledge of pharmaceutical GMP, guidelines and regulations (Health Canada, U.S. FDA Regulation 21 CFR Part 210, 211, etc.)
• Ability to remain current on the frequently changing regulatory and CGMP requirements

Interested and qualified candidates should forward resumes to:

karin@kma.ns.ca