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Quality Compliance Support Manager

Eingestellt von Next Ventures Ltd

Gesuchte Skills: Engineering, Support

Projektbeschreibung

Next Ventures is urgently looking for aQuality Compliance Support Manager based in Ufa, Russia.

Fluency in RUSSIAN and ENGLISH is a must.

REPORTING LINE: in the project, this QA function at our partner in Ufa will reporting to and receiving guidance and support from the Director External Supply Integration Quality (ESIQ); the function will form a team with the QA lead, already hired for that role and also working in Ufa.

TIME PERIOD:  full time begin Q2 2014 - end Q1 2015 (continuous presence 7 weeks per 8)

TASKS TO BE PERFORMED IN THE PROJECT:

- The objective of the function is to provide continuous professional hands-on consultancy and expertise to the client's partner in Ufa during the qualification, validation and start-up phases of a new sterile department for our product (plans, protocols, execution and reports).
- Because of the international nature of the assignment, a strong, independent personality is required, dynamic and with a lot of drive; he/she must speak English and also Russian, and must be willing to integrate into a completely different culture. Speaking other languages like Dutch and/or German is an asset.
- A team player is needed, who can adapt easily to different cultural environments (project-partners in US, Germany, Belgium, Switzerland, Russia and Czech Republic)
- In alignment with Process Engineering, the function is responsible that the production process is correctly implemented.
- The whole set of activities should be managed in such a way that agreed timelines, under responsibility of our local partner, are followed. All these activities should lead to successful process validation and commercial batches after regulatory approval; strong project management skills are required.

We are looking for a person, who can work in the Ufa-plant of our partner full time to support the processes described:

Quality systems
        The function should make sure that all quality systems at the Ufa plant are according to the client's expectations and are operated consistently and in compliance with GMP.
        The function should support and train local QA and other functions to reach an acceptable level of proficiency in operating the quality systems

QUALIFICATION (FAT/SAT - IQ/OQ): (also in cooperation with the Process Engineering Manager for the project)

- The function should focus on all new equipment validation with a link to our product. This includes manufacturing equipment such as filling, loading, lyophilisation, autoclave, isolators but also a sterility test isolator, sampling equipment, etc.
- Qualification of the compounding area is included (including isolator, CIP/SIP)
- The incumbent would be responsible for the protocols and reports evaluations, identify issues, resolve minor issues and escalate major issues as appropriate. In addition he/she would participate in the evaluation of the results of analytical and environmental method validations.

VALIDATION (PQ, MEDIA FILLS): (also in cooperation with Process Engineering Manager for the project)

- Supporting PQ which includes sterilization validation and media fills

In General: assist in LOCAL FOLLOW UP OF PROJECT AND QUALITY MANAGEMENT

The MAIN EQUIPMENT IN THE NEW PRODUCTION DEPARTMENT of our partner will be:

- Fully automated filling line including a washing machine, a depyrogenization tunnel, a filling machine, an automated lyo loading system, a crimping machine, etc.
- A lyophilizer
- Aseptic filling isolator
- Autoclave
- Formulation equipment, including automated CIP/SIP
- Small isolators: sampling, analytical, sterility test and formulation/dispensing isolator
- Outside vial washing
- Clean utilities, purified water, water for injection, clean-steam, etc.
- Cleanrooms, A - B - C and D graded areas
- Waste handling equipment
- Containment systems for cytotoxic products, etc.

Apply now

Projektdetails

  • Einsatzort:

    Keine Angabe

  • Projektbeginn:

    asap

  • Projektdauer:

    6months +

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Next Ventures Ltd