QA Technician

Piramal Healthcare UK Limited; Grangemouth; On-site; GBP 25,000 - 35,000; Full time

Job summary

Piramal Pharma Solutions is seeking a QA Technician to assist the QA officer with review of procedures, batch paperwork and manufacturing documentation. You will act as QA representative for campaigns, addressing process instructions, deviations, validation, and audits to ensure batch quality.

You will identify and escalate cGMP issues, support regulatory inspections and client audits, and promote a strong quality culture across the site.

Qualifications

• Experience performing QA review of GMP batch records.
• Familiar with change control, deviations, and CAPAs.
• Experience preparing QA documentation for audits.
• Commitment to data integrity and GMP compliance.

Responsibilities

• Provide QA support to GMP manufacturing, testing and related activities.
• Review and approve batch records, validation and GMP documentation for accuracy and compliance.
• Support deviation management including initiation, investigation, and closure.
• Review and approve QMS records such as deviations, change controls, CAPAs, and risk assessments.
• Support materials status and batch lifecycle activities for batch disposition readiness.
• Collaborate with Operations, QC, Regulatory functions to resolve quality issues.

Skills

GMP knowledge

Documentation

Deviation handling

Change control

Audit support

Data integrity

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal 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.comJob TitleQA TechnicianJob DescriptionThe 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 escalate cGMP issues that have the ability to effect batch quality.Key ResponsibilitiesProvide 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.