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Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.

Working independently to provide technical writing support to Manufacturing and Packaging Departments by creating and modifying Standard Operating Procedures (SOPs), Work Instructions (WI), Master Batch Records

(MBRs), cleaning validations, bulk hold studies, process validations and equipment qualifications.

SPECIFIC RESPONSIBILITIES:

• Create and modify GMP documents related to the Operations department, such as Standard Operating Procedures (SOPs), Work Instructions (WI), Master Batch Records (MBRs) and GMP training materials.
• Prepare and execute protocols/documents for cleaning, process and packaging validation and generate Validation Summary Reports in accordance with GMP and CPL’s Validation Master Plan.
• Generate and execute equipment and system’s qualification (Installation and Operation Qualification).
• Generate manufacturing and packaging instructions for new/existing products and/or processes by adapting customer processes to CPL’s equipment and operational requirements through data obtained during line and process test runs.
• Participate in product and process related problem-solving including investigations, process optimization, and support during client visits.
• Support, document and assist in execution of line trial and demonstration batch activities.
• Initiate change controls for batch records, process validation, cleaning validation and equipment qualifications.
• Assist in the development and modification of routings.
• Solicit input from the production floor, supervisors and engineers on written documentation to ensure clear understanding of work instructions.
• Develop work plans considering the department objectives, responsibilities, accountabilities, timelines, and resources.
• Keep appropriate individuals informed on progress of tasks/projects.
• Other duties as assigned.

QUALIFICATIONS:

• Diploma in Science, or in a related technical field.
• Two years of technical writing or communications experience.
• Minimum of two (2) years relevant experience in a pharmaceutical manufacturing/production environment which utilizes automated equipment.
• Must be able to understand technical drawings and documents and create simplified instructions that are easy to understand and follow.
• Proficient in using MS Office, including embedding annotations, pictures and video in instructions.
• Excels at creating visual documentation and reformatting existing documentation that is overly complex and challenging to understand.
• Able to handle multiple tasks simultaneously, good use of time to complete tasks and projects.
• Demonstrated competencies in CPL’s core values of Integrity, Respect, Trust and Fairness.
• Excellent verbal and written English communication skills.
• Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• Office environment.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation polices, please contact us.

We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.