QA Technician

Piramal Pharma Ltd; Grangemouth; Sur place; GBP 24 000 - 34 000; Plein temps

Résumé du poste

Piramal Pharma Solutions is seeking a QA Technician to support QA activities across GMP manufacturing, testing and documentation. The role involves reviewing procedures, batch records, change controls and deviations, and acting as QA representative for campaigns to ensure cGMP compliance.

You will collaborate with Operations, QC, MSAT, Supply Chain and Regulatory functions to resolve quality issues efficiently, prepare QA documentation for audits, and promote a culture of continuous improvement

Qualifications

• Assist QA officer in review of procedures and batch paperwork, ensuring accuracy and compliance.
• Act as QA representative for campaigns involving change control, deviation, validation and audits.
• Identify and elevate cGMP issues with potential impact on batch quality.

Responsabilités

• Provide QA support to GMP manufacturing, testing, and related activities.
• Review and approve master/executed batch records, validation and GMP documentation to ensure accuracy and completeness.
• Support deviation management from initiation, investigation to closure.
• Review and approve QMS records, including deviations, change controls, CAPAs, and risk assessments.
• Support material status control and batch lifecycle activities, including readiness for batch disposition.
• Ensure adherence to data integrity principles and GMP requirements across all activities.
• Support regulatory inspections, client audits, and internal audits through QA documentation.
• Collaborate with Operations, QC, MSAT, Supply Chain, and Regulatory to resolve quality issues efficiently and compliantly.
• Promote a strong quality culture and continuous improvement mindset on site.

Connaissances

QA knowledge

GMP

Documentation

Audit support

Collaboration

Description du poste

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

QA Technician

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.

Key Responsibilities

• Provide QA support to GMP manufacturing, testing, and support activities in line with approved procedures.
• Review and approve master/executed batch records, validation and other documentation, and associated GMP records to ensure accuracy, completeness, and compliance.
• Support deviation management, including initiation, investigation support, assessment/ review and closure.
• Review and approve QMS records in accordance with authorised roles, including deviations, change controls, CAPAs, and risk assessments.
• Support material status control and batch lifecycle activities, including readiness for batch disposition.
• Ensure adherence to data integrity principles and GMP requirements across all assigned activities.
• Support regulatory inspections, client audits, and internal audits through preparation and review of QA documentation.
• Collaborate with Operations, QC, MSAT, Supply Chain, and Regulatory functions to resolve quality issues efficiently and compliantly.
• Promote a strong quality culture and continuous improvement mindset across the site.