Job Title: Pharmaceutical Quality Assurance Manager
About the Role:
We are seeking a highly skilled Pharmaceutical Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:
* Manage the quality assurance team to ensure effective implementation of quality systems and processes.
* Oversee company quality assurance policies to ensure alignment with regulatory requirements.
* Maintain a Pharmaceutical Quality System according to GMP (Good Manufacturing Practices).
* Develop, review, approve, and maintain SOPs (Standard Operating Procedures) and quality assurance procedures.
* Assist with training staff on various practices and on standard operating procedures (SOPs) for new or updated processes.
* Work closely with other teams to implement changes to increase efficiency and to identify and establish corrective actions while still maintaining high levels of quality.
* Supervise the lifecycle of the products in place to ensure each step is completed correctly done and confirm that cannabis products are up to standards.
* Assist Qualified Person (QP) with Recalls and Complaints investigation and ensure they are performed according to quality and regulatory requirements.
* Develops quality assurance plans by conducting hazard analyses, identifying critical control points and preventative measures, establishes critical limits, monitoring procedures, corrective actions, and verification procedures.
* Manage site quality inspection activities, schedule and participate in compliance audits and where applicable, supplier quality assessments.
* Manage and support the validation and qualification studies.
* Manage the Change Controls and Deviations raised within the Quality System.
* Perform any other duties that may arise from time to time as a team, and as requested by the QP.
Requirements:
To be successful in this role, you will need:
* Bachelor or Master's Degree in Pharmaceutical Sciences, Chemistry, or related field.
* Minimum of 3 years of experience in a regulated organization for the production of medicines.
* Experience/knowledge demonstrated in ISO, GLP, GMP, QMS, or similar.
* Knowledge of written and spoken English.
* Ability to work in a result-oriented, challenging environment.
* Ability to react to urgent situations and leadership capacity.
* Excellent interpersonal and communication skills, including speaking and writing.
* Computer knowledge from the MS Office user perspective.
What We Offer:
As a valued member of our team, you will receive:
* Employment contract directly with the client.
* Base salary + other benefits offered by the client.
* Initial and continuous training.
* Integration into a dynamic and ambitious team.
Location:
The ideal candidate will be located at our site in Catanhede.