TÜV Rheinland Group
# FCCA Auditor **TÜV Rheinland North America** Join TÜV Rheinland, one of the world's leading testing, inspection, and certification service providers with more than 20,000 employees globally. We value our employees as our most important asset and invest in their development through competitive compensation, comprehensive health insurance options, and a 401(k) with up to 6% company match. Our international, team-oriented culture is built on respect, collegiality, and openness, enabling employees to develop their potential, apply new knowledge directly, and build long-term careers with real advancement opportunities. ## Position Summary As part of TÜV Rheinland's North American auditing team, the FCCA Auditor will conduct factory capability and capacity assessments (FCCA) according to Walmart's protocol. This role involves evaluating production planning systems, quality processes, workforce capacity, and order fulfillment capabilities of suppliers manufacturing for Walmart and Sam's Club. ## Principal Duties and Responsibilities • Conduct FCCA and Quality Management System audits in accordance with Walmart's FCCA audit protocol and relevant accreditation requirements • Lead audit teams and ensure successful completion of assigned projects • Assess management systems and verify production capacity, manufacturing systems, and quality control practices • Analyze production flow, line balancing, machinery, and staffing capacity • Identify discrepancies and non-conformities with Walmart's capability requirements • Communicate compliance issues, relevant standards, and audit findings to client management through verbal and written reports • Prepare detailed audit reports and submit findings on Walmart's designated platform or TÜV Rheinland's report templates • Maintain current knowledge of Quality Management System auditing and Walmart audit policies and related supply chain compliance programs • Perform additional duties as assigned ## Required Qualifications • Bachelor's degree, preferably in engineering, manufacturing, or related discipline • Minimum 3 years of experience in factory audits or manufacturing management • Successful completion of Walmart FCCA auditor training and certification (training provided) • Knowledge of production planning, workflow analysis, and lean manufacturing • Strong reporting, analytical, and communication skills • Willingness to travel within North America (up to 80% travel required) • Valid passport and driver's license ## Preferred Qualifications • ISO 9001 / Quality Management System auditor qualification • APSCA ASCA status ## Essential Skills and Abilities • Articulate, professional, and customer service-oriented approach • Excellent written and verbal communication and presentation skills • Ability to thrive in fast-paced environments and work effectively under pressure • Strong prioritization and multitasking capabilities • Excellent analytical skills • Knowledge of MS Office applications • Ability to interface effectively with all organizational levels ## Compensation and Benefits **Salary:** $85,000 - $95,000 annually **Employment Type:** Full-time, Permanent **Travel:** Significant travel required, including potential international assignments ## Equal Opportunity Employer TÜV Rheinland North America is committed to diversity and inclusion, ensuring nondiscrimination in all programs and activities. We continuously seek talented, qualified employees regardless of race, color, sex/gender, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizenship status, protected veteran status, or any other protected classification. We are proud to be an Equal Employment Opportunity/Affirmative Action Employer/Federal Contractor with priority referrals for protected veterans. Applications are accepted exclusively through our online application system.
CELOGEN PHARMA PVT LTD
**Quality Control Head** **Location:** Mehsana, Gujarat **About Company:** Celogen Pharma Pvt. Ltd. is a leading pharmaceutical formulations exporter and manufacturer based in India. We provide products and services across multiple countries globally, including West Africa, East Africa, South Asia, Southeast Asia, the Middle East, South America, and Europe. Beyond promoting our branded products in the retail sector, we actively participate in global tenders across numerous countries. Our team comprises first-generation marketing experts and some of the industry's finest technocrats. With four manufacturing facilities across India, we produce a diverse range of pharmaceutical products. This position is within our hormone formulation manufacturing division. **Job Summary:** The Head of Quality Control (QC) is a senior leadership position responsible for directing all laboratory operations related to testing raw materials, packaging materials, in-process materials, and finished pharmaceutical products. This role ensures all quality control activities comply with current Good Laboratory Practices (GLP) and applicable national and international regulatory standards. The successful candidate will drive the strategic direction of the QC function, ensuring high-quality, timely analytical support for manufacturing and product release. **Key Responsibilities:** **Analytical Testing:** - Perform routine and non-routine analytical testing using various techniques (HPLC, KF, Dissolution, Titration, Physical testing) - Ensure testing complies with approved pharmacopoeial methods and in-house specifications - Operate, calibrate, and maintain analytical instruments for optimal performance **Data Review & Documentation:** - Review analytical data, raw data, and laboratory notebooks for accuracy and compliance - Prepare and review Certificates of Analysis (COAs) and quality documents - Maintain detailed, organized laboratory records with timely documentation **Investigations & Deviations:** - Lead Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations - Identify root causes and recommend corrective and preventive actions (CAPAs) - Document and investigate laboratory deviations following established procedures **Method Development & Validation:** - Support development, transfer, and validation of analytical methods per regulatory guidelines - Conduct feasibility studies and provide technical input for method optimization **Strategic Leadership & Management:** - Develop and execute long-term QC department strategy aligned with business objectives - Lead, mentor, and manage the QC team while fostering a culture of quality and continuous improvement - Oversee daily laboratory operations, including scheduling, resource allocation, and infrastructure management **Regulatory Compliance & Quality Systems:** - Ensure compliance with cGMP, GLP, and pharmacopoeial requirements (USP, EP, JP) - Serve as primary QC representative during regulatory inspections and audits - Review and approve critical QC documentation, including SOPs and validation protocols **Cross-functional Collaboration:** - Partner with Manufacturing, Quality Assurance, Regulatory Affairs, and R&D teams - Coordinate with QA to evaluate and monitor supplier material quality - Support process improvements and meet production deadlines **Required Qualifications:** **Education:** Bachelor's or Master's degree in Analytical Chemistry or Organic Chemistry **Experience:** 8-10 years of progressive experience in Quality Control within pharmaceutical manufacturing **Essential Skills & Competencies:** - Proficiency in analytical instruments (HPLC, GC, UV-Vis, FTIR, KF, Dissolution apparatus) - Strong understanding of analytical method validation and transfer principles - In-depth knowledge of GLP and regulatory requirements (ICH guidelines) - Experience with LIMS (Laboratory Information Management System) preferred - Proficiency in Microsoft Office Suite - Excellent analytical, problem-solving, and critical thinking abilities - Strong attention to detail and accuracy - Outstanding written and verbal communication skills - Proven organizational and time management capabilities - Experience with pharmaceutical dosage forms (tablets, capsules, injectables, liquids) - Familiarity with Data Integrity principles **Employment Details:** - Job Type: Full-time - Salary: ₹35,000 - ₹60,000 per month - Work Location: In-person - Expected Start Date: July 15, 2025