Senior Manufacturing Process & Cleaning Consultant

We are seeking a Senior Manufacturing Process & Cleaning Consultant for the management of projects in the chemical-pharmaceutical sector, to support company growth.

Requirements:

  • Minimum experience of 3-4 years in Cleaning and Process Validation, preferably with solid oral products;
  • Previous employment in the pharmaceutical sector;
  • Technical Diploma and/or Degree in CTF, Pharmacy, Chemistry or Chemical Engineering;
  • Good knowledge of English (minimum level B1).

Responsibilities:

  • Drafting of cleaning and process validation documents (protocols, reports and VMPs);
  • Technical supervision of field activities on manufacturing processes (granulation, compression and coating of tablets);
  • Full autonomy in cleaning validation activities (document review, sampling and shift activities);
  • The ability to intervene, evaluate and resolve deviations or process anomalies, and to promptly provide indications and solutions;
  • Management of the documentary activities supporting the validation processes in and out of the field (correct compilation of documents and execution of sampling and IPCs);
  • The ability to perform extraction/statistical processing of process data for the drafting of validation reports.

What makes all the difference:

  • A consultative and collaborative approach with colleagues and clients;
  • A consolidated organisational capacity;
  • Distinct qualities as a team player, capable of encouraging constructive discussions and the sharing of information, both with internal collaborators and with clients or suppliers involved in the projects;
  • An excellent ability to manage stress, maintain control and focus on priorities;
  • An orientation towards quality;
  • Adaptability to change;
  • The ability to provide feedback on your own work.
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Paola Mongelli
PAOLA MONGELLI
Recruiter

DETAILS

SENIORITY LEVEL

Mid-Senior level

TYPE OF CONTRACT

Permanent

WORKING HOURS

Full-time with shifts (morning/afternoon/night)

PLACE OF WORK

Latina

AVAILABILITY

Immediate

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    COMPLAINTS

    An aid to inspection work

    Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

    The module is designed to provide step by step Quality Assurance support
    in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

    PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

    During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes

    AUDIT

    Documents and traces activities

    It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

    The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

    PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

    Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes