Quality Assurance Technician Pharma

Piramal Pharma Solutions; United Kingdom; On-site; GBP 30,000 - GBP 40,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking a Quality Technician to support Quality Assurance activities. This role involves reviewing documentation, ensuring compliance with cGMP standards, and participating in audits and investigations. Ideal candidates will have experience in a QA role within the pharmaceutical industry, with a strong understanding of regulatory requirements. The position offers an opportunity to contribute to the quality assurance processes of new products across various functions.

Qualifications

• Experience in a quality assurance role within a pharmaceutical environment.
• Understanding of regulatory requirements including MHRA/FDA.
• Proven ability to conduct audits and investigations.

Responsibilities

• Provide QA input to project activities including review and approval of change requests.
• Participate in quality related investigations and assist in developing effective CAPA.
• Identify cGMP areas of concern and elevate them.
• Participate in validation activities including preparation for regulatory audits.

Skills

cGMP knowledge

Quality Assurance

Investigative skills

Attention to detail

Job description

The Quality Technician will assist the QA officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. Be the QA representative for new campaigns dealing with aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition. The QA Technician is expected to identify and elevate cGMP issues that have the ability to effect batch quality.

Role

• Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
• Participate in quality related investigations, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
• Identify and elevate any identified cGMP areas of concern.
• Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures.
• Participate in the audits of suppliers, production and support functions as required.
• Be involved in the preparation for MHRA/FDA and other regulatory body audits.
• Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
• Reviewing manufacturing, laboratory and associated documentation prior to performing the relevant disposition of final products. Where potential issues exist, these are to be highlighted to the QA manager.
• Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC and manufacturing thus ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.