QA Technician

Piramal Pharma Limited; Falkirk; On-site; GBP 28,000 - 32,000; Full time

Job summary

An established industry player is seeking a QA Technician to ensure compliance with cGMP standards in the pharmaceutical manufacturing sector. This role involves providing quality assurance input to project activities, participating in audits, and collaborating with multi-functional teams to introduce new products. The ideal candidate will possess strong communication and organizational skills, along with a solid background in quality assurance and analytical chemistry. Join a dynamic team where your contributions will enhance product quality and safety in the pharmaceutical industry.

Qualifications

• 3+ years of experience in a cGMP environment manufacturing Active Pharmaceutical Ingredients.
• Strong background in quality assurance and analytical chemistry.

Responsibilities

• Provide QA input to project activities and review documentation.
• Participate in quality investigations and develop CAPA.
• Act as QA representative for new product introductions.

Skills

Attention to detail

Good communication skills

Good organisation skills

Ability to work effectively individually

Ability to analyse data

Ability to identify root causes

Ability to prioritise workload

Ability to follow instructions

Ability to escalate issues

Education

BSc in a relevant Scientific discipline

College/University qualification in a scientific subject

Job description

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• 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 escalate 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.
  
  
• Good communication skills, both verbal and written
• Good organisation skills
• Ability to work effectively individually and as part of a team
• Ability to analyse data and information to make considered decisions
• The ability to identify root cause of problems to determine appropriate solutions
• Ability to prioritise workload to ensure timelines are met
• Ability to follow instruction accurately
• Ability to escalate issues as appropriate
  
  

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, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
• Identify and escalate 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.
  
  

Competencies:-

• Attention to detail
• Good communication skills, both verbal and written
• Good organisation skills
• Ability to work effectively individually and as part of a team
• Ability to analyse data and information to make considered decisions
• The ability to identify root cause of problems to determine appropriate solutions
• Ability to prioritise workload to ensure timelines are met
• Ability to follow instruction accurately
• Ability to escalate issues as appropriate
  
  

Qualifications

Essential Qualifications:-

• BSc in a relevant Scientific discipline or equivalent.
  
  

Essential Experience:-

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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