Manbir Bilan

Experienced Quality Assurance Auditor with over 10 years of audit experience within regulated GLP environment and 15 years of experience working in GMP-regulated pharmaceutical environments. Strong expertise in internal and facility audits, CAPA, risk assessments, Quality Management Reviews, document control, quality documentation review, data integrity, ALCOA+ principles, Good Documentation practice (GDP), and Quality Management Systems (QMS). Analytical, detail-orientated, and highly organised professional with strong problem-solving, decision-making and communication skills.

Experienced in electronic quality management system and proficient in Microsoft Office, including Word, Excel and Outlook. Skilled in developing and delivering training to team members and operational departments. An effective and collaborative communicator who builds strong multidisciplinary relationships through professionalism, active listening, and respect for diverse perspectives.

Reliable and accurate team player with proven track records of contributing to quality, compliance and continuous improvement throughout a 25+ year career in the pharmaceutical industry.

QA AUDITOR IV, QUALITY ASSURANCE - Labcorp Early Development Laboratories Ltd - Derby, Derbyshire

(2025-05)

• Lead and conducted risk-based internal audits across facilities, processes and studies within highly regulated GLP/GxP environment, assessing the effectiveness of the Quality Management System and compliance with regulatory and company requirement.
• Review study plans, audit reports, SOPs, risk assessments, change control and quality records to identify compliance gaps, potential risks and recommended appropriate corrective actions.
• Provide independent QA oversight and clearly communicate audit findings, compliance risks and improvement opportunities to operational and quality stakeholders.
• Conduct quality management reviews and contribute to continuous improvement initiative designed to strengthen QMS effectiveness and maintain a state of inspection readiness.
• Support and facilitate client and regulatory audits, coordinate audit activities, document requests and responses to findings to ensure timely and effective resolution.
• Conduct Quality Risk Management activities and develop plans to identify, assess and mitigate risk to compliance, data integrity and study quality.
• Monitor CAPA implementation and effectiveness, challenging actions where appropriate and supporting timely, sustainable closure of audit findings.
• Provide training, coaching and mentoring to QA Personnel, promoting consistent application of quality standards, regulatory requirements and best practices.
• Act as knowledgeable QA resource, providing advice and support to operational tams on GxP/GLP compliance, quality requirement and risk management.
• Contribute to ongoing development and improvement of quality processes, supporting a proactive quality culture across the organisations.
• Actively contributing to global projects, collaborating with international teams and stakeholders.

QA AUDITOR III, QUALITY ASSURANCE - Labcorp Early Development Laboratories Ltd - Derby, Derbyshire

(2021-05 - 2025-05)

• Conducted internal facility, process and study-based audit to assess compliance GLP/GxP requirements, regulatory expectations and company procedures.
• Reviewed study plan, report, SOPs and quality records to identify compliance issues, assess risk and determine appropriate audit findings.
• Evaluated audit findings and supported the development, implementation and follow -up of corrective and preventive measures.
• Worked collaboratively with operational teams and quality teams to resolve compliance issues and promote continuous improvement.
• Supported inspection readiness activities and contributed to successful regulatory inspections through review of documentation, preparation activities and QA support.

QA AUDITOR (LEVEL I), QUALITY ASSURANCE | QUALITY ADVISOR, QUALITY ASSURANCE - Envigo Laboratories Ltd | Covance Laboratories Ltd - Derby, Derbyshire

(2015-09 - 2021-05)

• Progressed through QA roles with increasing responsibilities with auditing, quality oversight and regulatory compliance with GLP -regulated laboratory environment.
• Conducted internal facility, process and study-based audits to assess compliance with regulatory environments, quality and company standards.
• Reviewed study plans, reports, SOPs and quality records to identify compliance gaps and potential quality risks.
• Prepared and communicated clear, objectives, findings and supported appropriate corrective and preventive actions

SENIOR LABORATORY TECHNICIAN/SUPERVISOR - Harlan Laboratories Inc. - Derby, Derbyshire

(2012-05 - 2015-09)

• Supervised day-to-day pharmaceutical testing activities, ensuring compliance with GMP requirements and laboratory procedures.
• Reviewed, produced and approved analytical test results, laboratory records, and technical reports.
• Collaborated with clients and Business Development teams within a GMP-regulated pharmaceutical environment, supporting client requirements, project delivery and development of new business opportunities.
• Ensured compliance with GMP, pharmacopoeia requirements, SOPs, and regulatory standards.
• Oversaw and maintained laboratory equipment qualification, calibration, and maintenance activities.
• Supported internal, client, and regulatory audits, ensuring inspection readiness and timely resolution of findings.
• Collaborated with Quality Assurance and manufacturing teams to support product quality and compliance, also named signatory on report.
• Managed sample scheduling, workload and laboratory resources to meet project timelines and business objectives.
• Investigated OOS/OOT results and laboratory deviations.

LABORATORY LEADING TECHNICIAN - International Laboratory Services Ltd. (ILS) - Derby, Derbyshire

(2005-02 - 2012-05)

• Performed GMP analytical testing to support batch release of pharmaceutical products.
• Performed testing using techniques HPLC, GC, KF, FTIR, Raw material testing using pharmacopoeia (USP, EP & BP), Dissolution and numerous other wet chemistry techniques.
• Conducted storage stability studies to support product shelf-life determination.
• Manged and ran numerous storage stability trials successfully.
• Generated and reviewed analytical data to support shelf-life studies.
• Investigated OOS/OOT results and laboratory deviations.

LABOROTARY TECHNICIAN - International Laboratory Services Ltd. (ILS) - Derby, Derbyshire

(2000-04 - 2005-02)

• Performed GMP analytical testing to support batch release of pharmaceutical products.
• Performed testing using techniques HPLC, GC, KF, FTIR, Raw material testing using pharmacopoeia (USP, EP & BP), Dissolution and numerous other wet chemistry techniques.
• Supported batch release activities through timely testing and reporting of results.
• Ensured compliance with GMP, pharmacopoeia requirements, SOPs, and regulatory standards.

BACHELOR OF SCIENCE - Chemistry and Biology - Guru Nanak Dev University (1995-09 - 1998-09)