DEPARTMENT Quality Control Laboratory

REPORTS TO QC Laboratory Manager

MAIN PURPOSE OF ROLE
The Senior Product Development Analyst will be responsible for conducting product development work according to MHRA and EU GMP Guidelines.
The work will involve the development of various pharmaceutical presentations, with supporting stability data and being responsible for the associated development and validation of appropriate analytical procedures.

KEY RESPONSIBILITIES
Undertake analytical / product development work towards developing a pharmaceutical presentation for license submission, as determined by stake-holder.
Planning product development work in collaboration with the QC Laboratory Manager and associated stake-holders.
Performing laboratory tests in order to produce reliable and precise data/results, during product development, method development, stability testing, etc.
Perform Reverse Engineering of commercial products, as and when requested for Product Development work.
Performing analytical method validations / method transfers, as required.
Writing quality method development / validation protocols, and reports, and in a timely manner.
Providing support / guidance to other authors.
Provide analytical expertise to trouble-shooting analytical, production or customer related issues.
Performing / providing support to OOS investigations.
Providing mentoring / support to less experienced analysts.
Provide project updates, as appropriate, to QC Manager and associated stake-holders.
Complying with the Laboratory and 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
Carrying 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.
Maintaining all areas associated with the laboratory in a presentable condition and that are audit-ready at all times.
Assisting the QC Laboratory Manager and Quality Team as directed.
Ensuring laboratory consumables are available for undertaking of tests.
Using computers and performing mathematical calculations for the preparation of graphs.
Other duties as assigned.

KEY ACCOUNTABILITIES
Performing laboratory tests in order to produce reliable and accurate data/results.
Ensuring laboratory test data is legible and permanent, an original record and accurate.
Participate in laboratory self-inspections and regulatory inspections.
Maintain a good working knowledge of Company’s internal procedures and EU GMP and ensure laboratory work is performed according to the relevant Standard Operating Procedures.

PERFORMANCE STANDARDS
Punctual, maintain appropriate dress standards, be polite and courteous to internal and external customers at all times.
Ability to work as part of a team to achieve results
Ability to work independently and with multiple levels within the organization.
Ensure that they comply with the Company’s Policies and Procedures.
Managing the timely progress of required results and investigations.
To co-operate and build strong working relationships both internally & externally.
Providing technical support to new and existing projects.
Demonstrate flexibility and willingness to assist.
Reliable & strong work ethic.
To maintain professional standards at all times.

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

EXPERIENCE & COMPETENCES
Working experience within a Pharmaceutical Company in a similar role
Previous experience reviewing and analysing raw materials and finished products
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
Understanding 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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