Quality Services Specialist - MTL

Job description

Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us! Position summary: The Quality Service Specialist primarily supports commercial and customer quality document requests. Key Responsibilities: Develop Goals and Motivations for Excellence in Quality Support Services: Place the interests of the Commercial Team and the Customer first; our success depends on their success. Be highly responsive and timely to the Commercial Team and Customer Key Accounts. Meet deadlines; communicate status and delays to the Team and customers proactively. Pursue an unrelenting quest for quality; use speed and simplicity to achieve goals. Communicate pleasantly and effectively. Demonstrate professional etiquette and courtesy when interfacing with customers. Conduct oneself with the highest level of integrity and business ethics. Commit to teamwork; seek out and use the ideas and skills of all colleagues. Reach for the highest standards of performance; show a passion for winning. Commercial Team Support Function: Curate any and all Commercial Team, and direct Customer Requests - Process information received from Commercial Team personnel - Manage and prioritize information to ensure timely delivery - Organize and maintain documentation received and conduct follow-up as applicable - Liaise with QA/QC and Technical department to resolve customer requests - Complies with and adheres to all regulatory compliance areas, policies and procedures. - Identifies and implements “best practices” in Quality Services. - Performs other duties as assigned by Commercial Team in a proactive manner Manage and Maintain Pertinent Logs (QA Document and Technical): Keep the QA document and Technical logs updated Acknowledge requests within 48h if they are not completed Provide high-level summary of log status to the Senior Quality and Regulatory Manager and/or the Director semi-monthly Review weekly tasks and responsibilities with the Senior Quality and Regulatory Manager Customer CDA/QAA – Commercial Team Requests • Initial review, propose revisions, follow up, signature coordination, and completion of customer confidentiality agreements (CDA), customer quality assurance agreements (QAA) and any quality-related agreements (e.g. Quality Technical Agreements (QTA), Customer Commitment Letter (CSL), etc.) • Support the maintenance of the CDA and QAA log - Customer Questionnaires - A&C Standard Quality System Overview - SOP Document Master List - Organizational Chart - General Policy Statements • Customer Specific Questionnaires: provided to Key Customers - Initial review - Finalize, signature collection - Provide to Commercial Team, Customer Services, or directly to Customer • Product Regulatory Document Requests: - Residual Solvents statements (RS) - BSE/TSE, GMO, and Allergen product compliance statements - Allergen statements - Melamine statements - Metal Residues statements - No Animal testing statements - Other statements, e.g. Proposition 65 GRAS status, suitability etc. • Respond to Product Information Requests - Specifications - Typical COA - Certificate of Origin - Test Methods - Shelf Life Letter - Manufacturer and Supply Chain Information - Packaging Specification/Information - Storage Conditions Statement - Stability Statement, Stability Data - Example Label (Mater Label) - Other product information statement (e.g. supply chain, manufacturing flow chart (MFC), etc.) Document Delivery System Design, Implementation and Maintenance • Manage Excipient Information Packages based on IPEC guidelines • Manage the maintenance of Document Dossiers for A&C’s push products • Assist in the design and implementation of Web-based Specification, COA and SDS self-serve document access • Suggest other document types suitable for Web-based self-serve document access External Audits Support • Act as liaison in organizing the timing and set-up of customer audits Customer Requirements Initial Review • Initial review of customer requirements against: • Existing A&C products specifications • Proposed source materials specifications • New source materials specifications Ancillary tasks/Responsibilities: Support to the global team when required, ensuring flexibility for special assignments. Qualifications & Experience: Bachelor’s degree in science (Chemistry)or related field. Minimum of 3 - 6 years of experience in Pharma industry. Quality Systems Knowledge (ISO and GMP) 3 years experience. Member of the Order of Chemists. Industry knowledge. Functional/Technical Competencies & Skillsets Quality Systems knowledge (ISO and GMP). Proficiency in quality management systems and auditing techniques. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to read, understand and apply complex instructions/regulations. Ability to work independently and as part of a team. Attention to detail. Self-starter. SUPERVISORY RESPONSIBILITIES: N/A Actylis is an Equal Opportunity Employer. Actylis does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need..