Quality Assurance Manager - Loures, Portugal - Hovione

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Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

Assigning products or projects to ensure achievement of key area objectives - Manage the cGMP programs (e.g. validation, qualification, stability, environmental control)

Conduct regular inspections of the operational areas to verify compliance with cGMPs (e.g Internal Audits) - Represent the QA function in clients and regulatory audits or inspections

Manage and evaluate regularly data regarding the Key performance indicators established for the area - Identify indicators and actions that envisions standardization and systematization of everyday activities

Approve, on quality's behalf, IOPs, change control documents (PdAs) and process related documentation - Evaluate/approve equipment cleaning, qualification protocols and reports

Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with department strategic objectives - Monitor Communication's budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.

Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Responsible for projects associated with the reception of oral tablets and capsules (oral drug product development)

We are looking to recruit a Candidate:

Masters' degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field - Technical background preferred

Experience in oral solid drug product, capsules and tablets (mandatory) in commercial phase.

-Leadership experience and capabilities including the ability to influence and collaborate with peers and coach others;

Pharma Industry experience-Operations in GMP-regulated environmental, (pharmaceutical Industry );

Experience in Quality roles mandatory, production or others;

Audits experiences (internal and external);

Typically requires 7 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical Industry (mandatory)

Track record of overachieving targets - Possess solid knowledge of Quality, cGMPs, ICH and ISO guidelines and practices - Knowledge of Regulatory Affairs

Good communication skills (verbal and written) - Skilled at managing processes and tools

Fluency in English is a requirement

Leadership experience and capabilities including the ability to influence and collaborate with peers and coach others;

Pharma Industry experience-Operations in GMP-regulated environmental,

Experience in Quality roles mandatory, production or others;

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

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