Qc Manager Lazio

Qc Manager
Roma
Lazio, Lazio

Responsible for effectively managing and leading the quality control function, for ensuring proper quality controls and analysis on batches, consistently with regulatory and corporate policy and directives, and for successfully managing arising deviations.

Proactively manage team both in local and international complex projects having substantial and relevant economic impact

Assess and evaluate the introduction and replacement of the equipment and the related purchase order;

Ensure Technical support to Purchasing Department for consumer materials by analysing new proposals from providers, introducing more efficacious ingredients, supporting the description in the specification of the supply and the certification of providers so to meet the efficiency and efficacy target related cost savings.

Supervising the stability studies for the pharmaceuticals products by issuing and approving stability protocols, checking and verifying the findings related to the requirements defined by the company, escalating issues as necessary

Supervising the analytical activities and the registered data related to the different batches of finished goods, incoming materials and intermediate steps of manufacturing

Supervising all the activities related to process validation and process deviations

Supporting the QP to grant and protect patient security by ensuring drugs' pureness, integrity and efficacy.

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Supporting QP in performing his duties by providing the information needed to release the batch and reporting quality events like (deviations, out of specifications) that may undermine product quality and efficacy.

Granting that all the information needed to QP performance are promptly reported so to taken duly and proper aware decisions; proactively cooperate during investigation activities and meeting both internal and external regulatory requirements

Granting that structures, headcount and approved procedures are available for effective managing of samples, analitycal tests, packaging materials, bulk products, , finished good and, if requested, monitoring the environment requirements set in GMP

Granting the registrations are effected both manually and trough registration tools to evidence that samples have been analysed, the due controls have been operated and that the deviations have been completely registered and investigated;

Granting that the finished goods includes drug substances complying with the quantitative and qualitative mix required by the Marketing authorisation and that are consistent with the related requirements and that are packed into proper container, duly labeled

Granting that a sufficient number of manufactured samples of products and initial materials are preserved so to perform future exams of the products, if needed

Approve or reject starting materials, packaging materials, half-finished goods or finished goods

Ensure monitoring and checking of production environment, plant and products stockpile warehouse hygiene;

Ensure full support to the investigation phases in the site so to coordinate the harmonisation and activation of compliance intervention.

Issuing and checking the department procedures.

Coordinates activities related to technology transfer by defining protocols, leading and verifying analitical test with the home site so to comply with the authorisation process of product release.

Planning and revising analtical validation methods

Proactively collaborate in defining career and development plans for his own reports

Develops and maintain effective organization by properly manage resource development by releasing training, coaching and continuous feedback and granting that the activities of the resources are in line with the company procedures.

Lead quality events investigation and resolution

Identify possibilities of improvement and efficiency in the analytical processes

Guarantee that the analytical Activities linked to New product introduction (methods transfer and validation) are performed within scheduled timing

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7, 000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative.

dynamic pac