QA Officer in Falkirk

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.

The Quality Assurance officer will act as the Quality Assurance representative for campaign projects, ensuring accuracy and compliance of procedures, quality management system records, manufacturing batch records and associated testing. Be the QA representative for new products and for change projects, dealing with aspects including review/approval of process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition. The QA officer is expected to identify, escalate and work to address any GMP/GxP issues with potential impact to product quality or quality compliance.

Summary: Piramal Healthcare UK Limited is seeking a meticulous and dedicated QA Officer to ensure the highest standards of quality and regulatory compliance within our pharmaceutical operations. This role is crucial in upholding our commitment to patient safety and product excellence.

Responsibilities:

• Perform routine quality assurance checks on manufacturing processes, raw materials, in-process materials, and finished products according to established SOPs and regulatory guidelines (e.g., GMP, GLP).
• Conduct internal audits and participate in external audits (e.g., regulatory inspections, customer audits) to identify areas for improvement and ensure compliance.
• Review and approve batch manufacturing records, packaging records, and laboratory data for completeness, accuracy, and adherence to specifications.
• Investigate deviations, non-conformances, and out-of-specification results, including root cause analysis and proposing corrective and preventive actions (CAPA).
• Manage and maintain the Quality Management System (QMS) documentation, including SOPs, protocols, and reports.
• Participate in change control processes, risk assessments, and product quality reviews.
• Support the training of personnel on quality system requirements and good manufacturing practices.
• Collaborate with production, QC, and R&D departments to resolve quality-related issues and promote a culture of quality throughout the organization.
• Prepare quality trend reports and present findings to management.
• Ensure compliance with all relevant national and international pharmaceutical regulations.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Proven experience (typically 2+ years) in a Quality Assurance role within the pharmaceutical or a closely regulated industry.
• In-depth knowledge of GMP (Good Manufacturing Practice) regulations, ideally including MHRA and FDA requirements.
• Experience with Quality Management Systems (QMS) and documentation control.
• Strong analytical and problem-solving skills, with experience in root cause analysis and CAPA implementation.
• Excellent attention to detail and strong organizational skills.
• Effective written and verbal communication skills, with the ability to articulate complex quality issues clearly.
• Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team in a fast-paced environment.
• Understanding of pharmaceutical product lifecycle and quality risk management principles.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.