Medical Devices and Dietary Supplements
About SASMAR
Sasmar Pharmaceuticals is a growing multinational manufacturer of family planning and fertility products. We have a strong focus on delivering products that benefit the lives of consumers and our brands hold leading positions globally.
Department function
As a crucial link between SASMAR, its products and regulatory authorities (including Belgium AFMPS & U.S FDA), you ensure the appropriate quality, safety and efficacy of our products. You have excellent knowledge of Quality Management systems and preferably ISO 13485 / ISO 9001 certifications.
As a QA manager you will be responsible for performing lot releases of finished products and maintaining accurate records to ensure the reliability of the company QMS.
You write clear, accessible product labels and provide strategic advice to senior management throughout the development of new products. Liaising with our network of distribution partners your ability to communicate with different cultures, analyse and filter document requests to prepare and accelerate regulatory submission approvals.
To be successful in this role you will require agility to be able to manage multiple tasks to ensure timelines are met.
General Responsibilities
Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
Communicates effectively with business stakeholders
Maintains knowledge of relevant industry information affecting quality and compliance
May provide responsive and proactive quality and compliance advice to defined customers.
Supports quality and compliance risk management for functional area using risk framework standards to define risk and develops mitigation recommendations
Audit
Plans, leads, conducts and reports on internal and external audits
Works with contract personnel to prepare, conduct and report outsourced audits
Manages supplier qualifications
Identify gaps during supplier qualification assessments
CAPA
Management of nonconformities, action plans and resolution effectiveness
Assesses need and assists in development of CAPA plans, approves and monitoring assigned audits
Assists with the continuing follow-up of agreed audit CAPA actions
Who you are
Bachelor in Science
Experience in pharmaceuticals or a related industry
Excellent analytical, written and oral communications skills
Fluent in written and spoken English and French
High ethical standards, trustworthy, operating with absolute discretion
Collaborative, influencing and interpersonal skills - curious to understand business environment
Skilled at managing & using technology
Ability to develop professional networks with stakeholders
Audit Experience
Supplier qualification knowledge
Who we are
At SASMAR, we do things a bit differently. There is no corporate politics and our teams have the freedom to problem solve independently. Our products are world leaders, helping couples in more than 70 countries internationally connect with each other better. Our fertility brand, Conceive Plus does a great job increasing the fertility rate and is loved all over the world and trusted by millions of couples it helped to conceive.
We are on a mission to be the brand of the future in personal care and we are always looking for good people to join us. Created in Sydney our style is different to other pharma companies but our principles of honesty, ethics, loyalty and trust still show in everything we do.
Please forward your CV in PDF format.