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Quality Control Validation Analyst

U254

12-month fixed term contract. To provide analytical support to a range of production processes.

Category:
Control Quality
Location:
United Kingdom
Date Posted:
11/04/2019
Days Remaining:
12
Employment Type:
Contract

Cambridge

BROAD PURPOSE OF JOB:

To provide analytical support to a range of production processes and product families.

To actively contribute to the progression of ongoing process validation projects by conducting all aspects of analytical testing using a variety of analytical techniques.

The overall analytical validation process must be comprehensively documented, with all the necessary procedures and reports in place.

SPECIFIC DUTIES AND RESPONSIBILITIES:

Performing analytical work in support of validation projects that cover product process improvements, introduction of new material and equipment.  

Proficient with a variety of software and information systems.

Attention to detail, strong organiz682804.995648ational, effective interpersonal and communication skills.

Must be able to interact effectively across a multi-disciplinary team.

Be able to present data and critical review data for regulatory submissions.

Maintain accurate written records and reports in accordance with GMP/GLP.

Understanding of ICH guidelines, Pharmacopoeias and current regulatory expectations to ensure appropriate compliance within projects.

Working knowledge and ability to proficiently operate a variety of analytical equipment; e.g. HPLC, KF, Dissolution, Particle Siz682804.995648e.

Understanding/Knowledge of wet chemistry.

Independently carries out all aspects of analysis to provide right first-time quality results.

 

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