DEPARTMENT Quality Control Laboratory
REPORTS TO QC Laboratory Manager / Senior QC Analyst’s

MAIN PURPOSE OF ROLE
The QC Laboratory Analyst is responsible for conducting Quality Control testing and documenting laboratory testing in accordance with the MHRA and EU GMP Guidelines.
QC Laboratory Analyst will also be responsible for performing and assisting in the OOS investigations where required.

KEY RESPONSIBILITIES
Involvement in the control of Standard Operating Procedures.
Planning testing work load under the supervision of QC Laboratory Manager.
Performing laboratory tests to produce reliable and precise data / results.
Complying with the Company Standard Operating Procedures (SOP’s)
Complying with GMP and carrying out routine tasks accurately and following strict methodologies to carry out analyses.
Complying with company Health & Safety Policy and Procedures
To carry out any ad hoc duties as required by QC Manager or Senior Management Team
Ensuring laboratory test record data is recorded and stored in real time and in compliance to data integrity.
Preparing samples, standards and reagents according to the relevant procedures.
Maintain all areas other associated with laboratory in a presentable condition ready to being audited at any time.
Performing method validations / method transfers where needed.
Maintaining and operating standard laboratory equipment, for example titrators, pH meters etc.
Assisting the QC Laboratory Manager and Quality Team as directed.
Assisting QC Laboratory Manager or senior management in writing of validation protocols and linked reports.
Ensuring the laboratory is well-stocked for performing the tests.
Participating in self-inspections and regulatory inspections.
Using computers and performing mathematical calculations for the preparation of graphs.
Other duties as assigned.

KEY ACCOUNTABILITES
Performing laboratory tests to produce reliable and precise data / results.
Ensuring laboratory test data is legible and permanent, original record and accurate.
Participate in self-inspections and regulatory inspections
Maintain a good working knowledge of Company’s internal procedures and EU GMP

PERFORMANCE STANDARDS
To maintain a professional standard at all times.
To be punctual, polite and courteous to others at all times.
Good team working skills.
Ensure that comply Company’s Policy and Procedures.

QUALIFICATIONS
GCSE, Grade A-C in English, Math and Science
Degree in Chemistry, Biology or Pharmacy

EXPERIENCE & COMPETENCES
Working experience working within a Pharmaceutical Company in a similar role
Previous experience reviewing raw materials and Finished Product Testing
Previous experience assisting with self inspections and regulatory inspections

KNOWLEDGE & SKILLS
Good communication skills both written and oral
Good working knowledge of Good Manufacturing Practice, Standard Operating Procedures, Health and Safety Regulations and MHRA guidelines
Good knowledge of Quality Control testing techniques both instrument based and wet chemistry.
Good knowledge of HPLC & GC techniques.
Basic information relating to ICH guidelines and EU GMP Chapter 6 (Quality Control)
Ability to perform routine simple and complex calculations
IT literate in Microsoft Software Packages,
Excellent attention to detail

PERSONAL QUALITIES
Enthusiastic and highly motivated
Positive attitude and flexible approach to work
Reliable and punctual
Able to integrate well as part of a team

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