QA Team Leader (Compliance)

Piramal Healthcare UK Limited; Grangemouth; Presencial; GBP 65.000 - 90.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions in Grangemouth is seeking a QA Team Leader (Compliance) to own elements of the Pharmaceutical Quality Management System and strengthen site-wide compliance. You will advise on risk and improvements, coordinating QMS governance and supporting supplier audits and regulatory readiness.

The role requires robust GMP QA experience, strong GxP knowledge, and the ability to influence stakeholders across Quality, Manufacturing and IT.

Formación

• Experience in Quality Assurance within a GMP environment.
• Strong knowledge of GxP requirements and ICH guidance.
• Experience performing self-inspections and audits of suppliers.
• Experience monitoring deviations, investigations and CAPA within an QMS.

Responsabilidades

• Provide governance across key elements of the Pharmaceutical Quality Management System.
• Coordinate Quality Management Reviews and translate trends into actions.
• Support supplier qualification, audits, and self-inspections.
• Assist regulatory inspections and post-inspection follow-up.

Conocimientos

GxP knowledge

Audit experience

CAPA handling

Regulatory inspections

Educación

Degree in a scientific/engineering discipline

Descripción del empleo

Job Title QA Team Leader (Compliance)

Ready to take the next step in your Quality career and have a real impact on how pharmaceutical quality is delivered? We’re looking for an experienced QA Team Leader (Compliance) to join our Quality team at Piramal Pharma Solutions in Grangemouth. This is an opportunity to take ownership of important elements of our Pharmaceutical Quality Management System, working across the site to strengthen compliance, identify improvement opportunities and support a robust, inspection-ready quality environment.

The Opportunity

This is much more than maintaining quality systems. You’ll work closely with colleagues across Quality, Manufacturing, Engineering, Supply Chain, IT and Development, providing quality and compliance expertise while helping teams identify risk, resolve issues and continuously improve the way we work. You’ll have the opportunity to:

• Provide governance and oversight across key elements of the Pharmaceutical Quality Management System.
• Coordinate Quality Management Reviews and help turn quality and compliance trends into meaningful actions.
• Support supplier qualification and audit programmes, including self-inspections, vendor audits and customer audits.
• Support regulatory inspections and ensure effective pre-audit preparation and post-audit follow-up.
• Identify GxP trends and compliance risks and work with stakeholders to develop effective mitigation plans.
• Support quality investigations and the development and approval of effective CAPAs.
• Coordinate site QMS training and help maintain understanding of current regulatory and quality requirements.
• Work across the site to identify and implement continuous quality improvements.
• Maintain awareness of evolving quality standards, guidelines and industry best practice.

About you

We’re looking for someone who can bring strong technical quality knowledge and confidently work with stakeholders across the business.

• A degree in a relevant scientific, business, process or industrial engineering discipline.
• Experience within Quality Assurance in a GMP environment.
• Strong knowledge of GxP requirements and relevant UK, EU, US and ICH quality guidance.
• Experience performing self-inspections and/or audits of third-party suppliers.
• Experience monitoring Quality Management Systems, including deviations, investigations, CAPA and complaints.
• Experience implementing audit and vendor assurance processes.
• Strong attention to detail, risk-based decision-making and communication skills.
• The confidence to influence peers, senior managers and external stakeholders.
• Even better if you have Lead Auditor qualifications, experience supporting MHRA/FDA inspections, or experience maintaining pharmaceutical regulatory authorisations or Drug Master Files.

Why this role?

For an experienced QA professional, this role offers a particularly broad compliance remit. Rather than focusing on a single quality process, you’ll be involved across QMS governance, audits, regulatory compliance, CAPA, training, supplier assurance and continuous improvement, with significant interaction across the Grangemouth site.

Company overview

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

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.