Principal Scientist - Analytical

Job Title: Principal Scientist - Analytical Location : Bengaluru Department : Analytical (BGRC) About Syngene: Syngene ( ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines •Overall adherence to safe practices and procedures of oneself and the teams aligned •Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards •Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. •Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. •Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self •Compliance to Syngene’ s quality standards at all times •Hold self and their teams accountable for the achievement of safety goals •Govern and Review safety metrics from time to time Job Purpose To ensure Quality Control laboratories remain inspection-ready and compliant with cGMP, GLP, Data Integrity, and global regulatory requirements. The role is responsible for managing QC compliance systems, Qualifications, supporting regulatory inspections and customer audits, investigating quality events, and driving continuous quality improvements. Key Responsibilities QC Compliance Management •Ensure compliance of QC laboratory activities with cGMP, GDP, GLP, ALCOA+, and Data Integrity requirements. •Review laboratory documents, SOPs, protocols, reports, specifications, and analytical records. •Drive periodic compliance reviews and gap assessments within QC operations. •Monitor adherence to internal quality systems and regulatory requirements. Regulatory & Customer Audits •Provide leadership and support during external audits performed by regulatory bodies, including FDA and MHRA, as well as audits conducted by partners, customers, and other auditing bodies. •Act as QC subject matter expert during audits and inspections. •Prepare audit responses and coordinate closure of audit observations. •Track commitments and effectiveness of implemented actions. Quality Systems •Manage and review QMS : Deviations, OOS, OOT, CAPA, CC, RA. •Conduct root cause investigations using quality risk management tools. •Ensure timely closure of quality events. Data Integrity Oversight •Perform periodic reviews to ensure compliance with ALCOA+ principles. •Conduct data integrity assessments for chromatography systems and laboratory software. •Support remediation activities and implementation of data integrity controls. Documentation & Training •Review and approve QC SOPs, policies, and quality documents. •Ensure training compliance of laboratory personnel. •Conduct GMP and Data Integrity awareness training programs. Continuous Improvement •Implement initiatives to strengthen inspection readiness. •Analyze compliance metrics and trends. •Participate in digitalization and quality excellence projects. Educational Qualification •. Chemistry / Analytical Chemistry •M.Pharm / B.Pharm •Equivalent life sciences qualification Experience •8 -10 years of experience in Pharmaceutical, Biopharmaceutical, CRO, CDMO, or API industries. •Minimum 3-5 years in QC Compliance, Quality Systems, and Regulatory Audit Management. •Experience handling regulatory inspections and customer audits. Technical Skills •cGMP and GLP regulations •21 CFR Part 11 & GAMP 5 – Computer System Validation requirements •Data Integrity (ALCOA+) •Thorough knowledge in EMPOWER CDS & other computerized systems •OOS/OOT Investigations •CAPA Management •Change Control Systems •Audit Management •Risk Assessment Tools •LIMS, LMS, EDMS, SAP, TrackWise, Empower, LabWare •FDA, EMA, MHRA inspection requirements Key Competencies •Regulatory inspection management •Strong investigation and problem-solving skills •Stakeholder management •Excellent technical writing and communication •Attention to detail •Leadership and mentoring capability •Cross-functional collaboration Key Performance Indicators (KPIs) •Audit observation closure on time •CAPA effectiveness rate •Compliance review completion •Inspection readiness score •Reduction in recurring deviations •Data Integrity compliance metrics •Successful regulatory inspections Preferred Experience •Exposure to USFDA, MHRA, EMA, ANVISA inspections. •Experience in Small molecules, Large Molecules, or Analytical QC laboratories. •Track record of leading major customer and regulatory audits with successful outcomes. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.