Senior QC analyst

Werkgever CheckMark Labrecruitment
Plaats Amsterdam area
Provincie Noord-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum dinsdag 1 mei 2018
Sluitingsdatum dinsdag 29 mei 2018

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Functieomschrijving

Wihtin the QC chemistry team of our pharmaceutical client in the Amsterdam area there is room for an experienced / senior (QC) analyst. The focus of this postion will be on the non-routine QC activities. Interested? Apply now!

As senior QC analyst you will work in dayshift and support the value stream organizational structure, take care of all non-routine Quality Control activities.

Responsibilities:

- Quality Control testing of Raw materials, API, Packaging components (primary and printed) Drug Product throughout manufacturing process and during shelf life of the drug product (Stability testing) according to GMP guidelines
- Handling failure investigations (OOS, CAPAs, GRAs, audits, etc)
- Documentation
- Stability (studies, review and approval of stability trend & evaluation reports)
- Train and/or supervise training of other lab staff and coordinate employees rotations to include instruction in laboratory methods and procedures
- Implement department policies and objectives
- Regulatory authority inspections
- Represent the department from a quality perspective to customers and professional

Profiel

Opleiding HBO
Ervaring Ervaren (3 - 8 jaar)
The Senior QC Analyst should have a MSc education (Pharmacy / Analytical Chemistry)or BSc+ / HLO+ with several years of experience in a manager position in the pharmaceutical industry.

Further requirements:

- Experience with pharmaceutical processes, chemical analysis techniques, and cGXP
- Experience on instrument like HPLC, GC, KF.
- Familiar with process automation.
- Familiar with Lean Lab concept.
- Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA
- Good Knowledge of English (verbal and in writing)

Aanvullende informatie

- Secondment through Checkmark until end June 2018, possible extension.
- You will work in dayshift.

Contact

Neem voor meer informatie contact op met Barbara Razenberg: 020 820 44 30 // 06 54 96 30 07
Vacaturenummer: 5782

Bedrijfsprofiel

Our client markets a range of specialty medicines, generic medicines, active pharmaceutical ingredients and over the counter products. Covering 36 countries, including the 28 European Union member states, they are Europe’s biggest provider of generic medicines.

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