QA Technician

Piramal Pharma Ltd; Falkirk; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks a Quality Assurance professional to ensure compliance with cGMP standards. The role involves reviewing documentation, participating in audits, and collaborating with various departments to maintain quality in production. Ideal candidates will have a BSc in a scientific discipline and at least three years of relevant experience.

Qualifications

• Minimum of 3 years’ experience in a cGMP manufacturing environment.
• Experience with quality assurance and analytical chemistry is beneficial.

Responsibilities

• Provide QA input to project activities and review documentation.
• Participate in quality-related investigations and audits.
• Act as the QA representative for new product introductions.

Skills

Attention to detail

Effective verbal and written communication skills

Good organizational skills

Ability to work independently

Data analysis and decision-making skills

Root cause analysis

Problem-solving abilities

Workload prioritization

Accurate following of instructions

Appropriate issue escalation

Education

BSc in a relevant scientific discipline

Job description

Job Description

Key Roles and Responsibilities:

• 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 and assist in the development and approval of effective CAPA to resolve production, audit, and customer issues.
• Identify and escalate any 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 audits of suppliers, production, and support functions as required.
• Assist in preparations for MHRA/FDA and other regulatory body audits.
• Review documentation related to incoming raw materials and perform disposition activities as required.
• Review manufacturing, laboratory, and related documentation prior to final product disposition, highlighting potential issues to the QA manager.
• Act as the QA representative for new product introductions, collaborating with R&D, QC, and manufacturing to ensure all cGMP documents and requirements are met.

Competencies:

• Attention to detail
• Effective verbal and written communication skills
• Good organizational skills
• Ability to work independently and as part of a team
• Data analysis and decision-making skills
• Root cause analysis and problem-solving abilities
• Workload prioritization to meet deadlines
• Accurate following of instructions
• Appropriate issue escalation

Qualifications

Essential Qualifications:

• BSc in a relevant scientific discipline or equivalent

Essential Experience:

• Minimum of 3 years’ experience in a cGMP manufacturing environment for Active Pharmaceutical Ingredients
• College/University qualification in a scientific subject
• Experience with quality assurance, analytical chemistry, development, and manufacturing groups is beneficial