Quality assurance and regulatory professionals

SHRIJI LOGISTICS LIMITED; Ovingdean; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading logistics and quality assurance firm in the UK is looking for a qualified individual to conduct GMP audits in the pharmaceutical industry. The ideal candidate will possess a degree in a relevant field and have experience in regulatory compliance. Responsibilities include negotiating audit findings and ensuring the effectiveness of the audit program. This role requires strong communication and strategic thinking skills, and the ability to travel internationally up to 50% of the time.

Qualifications

• Experience performing internal and/or external GMP audits.
• Subject Matter Expertise in areas such as Biologics or Medical Devices.
• Quality compliance experience in regulated industries.

Responsibilities

• Conduct audits and ensure post-audit activities are completed.
• Negotiate corrective actions with external firms.
• Lead and coordinate responses to audit findings.

Skills

Regulatory interpretation

Quality Management Systems

Communication

Negotiation

Strategic thinking

Adaptability

Education

Degree in Science, Chemistry, Biology, Engineering

Job description

Responsibilities

• Accountable for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post-audit activities are completed within defined timeframes.
• Negotiate with external firms to attain acceptable corrective actions and independently generate extensive, high-quality GMP documentation, with communication and partnership across divisional oversight groups and commercial sites.
• Schedule and perform assigned audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, CAPA receipt) meet established expectations.
• Maintain broad-based expertise of cGMP, Company Policies, Procedures and Guidelines, regulatory requirements, and other topics pertinent to the pharmaceutical industry (e.g., Biologics, Medical Devices, Small Molecules, Combination Products, APIs, Controlled Substances).
• Obtain and maintain cutting-edge knowledge, application, and certification for various technical/quality auditing topics.
• Maintain awareness of evolving industry and regulatory trends/regulations.
• Support New Business opportunities through Due Diligence (electronic and on-site) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions.
• Assist with preparation of the annual audit schedule using risk-based approaches for auditor assignment.
• Lead and coordinate with Procurement and impacted Site Quality on critical audit findings or audit refusals; generate comprehensive presentations/summary of issues for effective communication at all levels, ensuring required assessments are performed.
• Lead initiatives to drive results in various projects to maintain the effectiveness and efficiency of the audit program and ensure it meets site, management, and regulatory expectations.

Education Minimum Requirement

• Hold a degree level qualification in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).

Required Experience and Skills

• Experience performing internal and/or external GMP audits in manufacturing, technology, and/or quality operations within EU/FDA, API, Drug Product, Medical Device or equivalent environments.
• Subject Matter Expertise in one or more areas such as Medical Device/Combination product, Biologics, Vaccines, or Sterile Drug Product manufacture.
• Quality/compliance experience in an EU/FDA-regulated industry with thorough understanding of Quality Management Systems and processes to support API/drug product and medical device manufacturing, including risk management.
• Strong regulatory interpretation skills and ability to apply requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• Excellent communication, negotiation, facilitation, influencing, and strategic thinking skills at all organizational levels.
• Positive change agent with adaptability in a dynamic environment.
• Ability to travel globally approximately 50% of the time (domestic and international).
• Hold a valid, clean driver’s license.

Preferred Experience and Skills

• Prior experience at a health authority performing GMP inspections.
• Demonstrated ability to lead and drive results for critical business/compliance initiatives.
• Lean Six Sigma belt or demonstrated process improvement experience.
• Knowledge of Quality by Design development and submission requirements.
• Experience with development, implementation and optimization of IT tools to deliver business outcomes.