Quality Operations Specialist

Position Overview

Join an international and dynamic team within our Life Sciences division, contributing to pharmaceutical manufacturing by upholding top-tier quality standards and regulatory compliance in a fast-growing organization.

Key Responsibilities

• Review and approve electronic batch records following Good Manufacturing Practice (GMP), internal protocols, and regulatory criteria.
• Detect inconsistencies, errors in documentation, and issues related to data integrity within electronic batch records.
• Work closely with Production, Quality Assurance, and additional teams to investigate and resolve issues found in batch records.
• Facilitate timely examination and approval of manufacturing documents.
• Perform internal audits or reviews of electronic batch records and document observations.
• Assist in investigations of deviations, implement corrective and preventive actions, and ensure thorough follow-up of documentation.
• Offer guidance and training on good documentation practices and electronic recordkeeping standards to relevant personnel.
• Contribute to initiatives aimed at continuous improvements in batch record reviews and quality management processes.
• Maintain electronic record-keeping systems ensuring compliance with data integrity standards.

Candidate Profile

• Experience with electronic batch records or electronic document management systems.
• Strong understanding of GMP, good documentation practices, data integrity, and pharmaceutical regulatory requirements.
• Educational qualification includes a Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Life Sciences, or a related field.
• Fluency in English is required; additional languages are advantageous.
• Exceptional attention to detail, analytical skills, and capability to identify and resolve documentation issues.
• Effective communication and stakeholder management abilities.
• Adeptness at collaborating with Production, Quality, and cross-functional teams.

Benefits

• Be part of a multicultural community comprising over 110 nationalities.
• A culture valuing trust, evident as 70% of key leaders began at entry-level positions within the company.
• Access to extensive professional development via an internal academy offering 250+ training modules.
• A lively workplace environment with frequent social and team-building events.
• Opportunities to engage in sustainability and social impact projects supported by the company’s ESG commitments and WeCare Together program.

Additional Information

Amaris Consulting emphasizes equal employment opportunities and actively promotes workforce diversity and inclusion. Applicants from all backgrounds, regardless of gender, sexual orientation, ethnicity, age, disability, or other characteristics, are encouraged to apply.

About the Company: Amaris Consulting is an independent tech consultancy with a global presence of over 7,600 employees across 60 countries, delivering expertise across Information Systems, Digital, Telecom, Life Sciences, and Engineering sectors.

Recruitment Process

• Initial Screening Call: A brief virtual or phone conversation to understand candidate motivation and suitability.
• Interviews: Typically involves three interviews with future supervisors and relevant team members, covering experience, skills, role expectations, and company culture.
• Case Study/Test: May include role plays, technical tests, or problem-solving scenarios depending on the position.