JOB DESCRIPTION Job Title: Head - Quality Control Job Location: Mangalore Job Level: Experienced About Syngene: Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose: Provide strategic leadership and oversight of the Quality Control (QC) function to ensure robust analytical operations, regulatory compliance, data integrity, and continuous improvement for small molecules APIs including tides. The role is accountable for delivering high-quality analytical outputs, maintaining audit readiness, and fostering a culture of safety, quality, and operational excellence. Job Responsibilities 1. Strategic Leadership & Governance <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Lead the QC function with accountability for end-to-end analytical operations, compliance, and performance.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Define and implement QC strategy aligned with organizational quality objectives and regulatory expectations.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Establish strong governance for quality systems, data integrity, and compliance oversight.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Act as the primary escalation point for all QC-related risks, compliance issues, and critical decisions.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 2. Regulatory Compliance & Quality Systems <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure compliance with cGMP, GLP, GDP, Data Integrity, and global regulatory requirements (USFDA, EMA, MHRA, PMDA, etc.).</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Provide strategic direction for handling QMS events including deviations, OOS, OOT, LIR, and product quality complaints.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure robust investigation practices, timely closure, and CAPA effectiveness.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Drive proactive identification of gaps and implementation of best-in-class compliance practices.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 3. Laboratory Operations Excellence <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Oversee all QC laboratory activities including raw material, intermediate, API, stability, in-process, and cleaning sample testing.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure on-time batch release and analytical deliverables without compromising compliance.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Maintain laboratory operations in a continuous Audit-Ready (ATAR) state.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Drive initiatives to improve productivity, Right First-Time (RFT) performance, and reduction in laboratory errors.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 4. Technical & Scientific Leadership <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Serve as technical authority in analytical sciences, microbiology, environmental monitoring, and method lifecycle management.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Review and approve critical documents including VMP, URS, validation protocols/reports, specifications, SOPs, COAs, and trend reports.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure alignment with latest regulatory expectations and pharmacopeial updates.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 5. Equipment, Infrastructure & Resource Management <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure robust systems for instrument calibration, qualification, and preventive maintenance.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Oversee qualification of facilities, utilities, and analytical equipment.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure availability of manpower, materials, reagents, and infrastructure.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Support new product introductions and regulatory changes effectively.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 6. Audit & Inspection Leadership <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Lead QC readiness for regulatory, client, and internal audits.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure timely audit responses, closure of observations, and CAPA effectiveness verification.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Represent QC during regulatory inspections and client interactions.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 7. Data Integrity & Compliance Oversight <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure adherence to Data Integrity principles (ALCOA+).</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Drive awareness, training, and monitoring programs.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Establish systems to prevent, detect, and remediate data integrity risks.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 8. People Leadership & Capability Development <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Build and lead a high-performance QC team.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure training, qualification, and completion of mandatory programs.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Provide coaching on GMP, investigations, and technical competencies.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Foster a culture of accountability, ownership, and continuous improvement.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 9. Cross-Functional & Client Collaboration <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Collaborate with Manufacturing, QA, Regulatory, and other cross-functional teams.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure timely material release and project deliverables.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Maintain strong client communication and stakeholder engagement.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 10. Continuous Improvement & Innovation <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Lead initiatives to enhance laboratory efficiency, productivity, compliance robustness, and digitalization.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Drive decisions using trend analysis and performance metrics.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Promote adoption of best practices and new technologies.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 11. Financial & Business Management <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Manage QC budget and cost optimization initiatives.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure efficient resource utilization and productivity improvements.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Prepare MIS reports, dashboards, and management updates.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 12. Documentation & Review Oversight <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Review and approve analytical records, COAs, change controls, deviations, and validation documents.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure documentation compliance with regulatory and audit requirements.</li> </ul> <div style="text-align:center" align="center"><hr align="center" size="2" width="100%"></div> 13. EHS & Safety Culture <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Drive a strong “Safety First” culture.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure compliance with EHS policies and regulatory requirements.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Monitor safety metrics and implement risk mitigation strategies.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ensure accountability towards zero incident goals.</li> </ul> Educational Qualification: M.Sc. (Chemistry), B Pharma/M Pharma or any other equivalent university degree. Technical/functional Skills: <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:normal;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif">Good communication skills and experience in small molecules API (Including tides) industry.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Regulatory and compliance expertise</li> </ul> Behavioural Skills: <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Good speaking-listening-writing skills, attention to details, proactive self-starter.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ability to work successfully in a dynamic, ambiguous environment.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ability to meet tight deadlines and prioritize workloads.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Ability to develop new ideas and creative solutions.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Strategic leadership & decision-making</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Stakeholder and client management </li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Continuous improvement mindset</li> </ul> Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Head QC (Dakshina Kannada, KA, IN, 574142) @ syngeneinternational

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