Position Overview: We are seeking a dedicated and experienced Quality Control Analyst to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the highest quality standards in our analytical processes, documentation, and laboratory operations. Key Responsibilities: Analyst Qualification & Training: Oversee the qualification process for analysts. Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices. Documentation Management: Prepare and review critical documents, including Specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Transfer Protocols (MTP), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR). Analytical Data Review: Review analytical data for routine samples, including in-process samples, Drug Substance (DS), Drug Product (DP) release, and stability samples. Oversee method transfer and method validation processes. Reference Standards & Material Management: Manage reference standards and oversee the indenting process for materials required in QC. Calibration Coordination: Coordinate with external vendors for instrument calibration. Collaborate with QC personnel for in-house calibration and verification of laboratory instruments. Laboratory Equipment Maintenance: Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance. Method Validation & Transfer: Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results. Quality Incident Management: Initiate and investigate incidents, deviations, change controls, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA), and Out of Trend (OOT) findings. Analysis Planning: Plan and schedule analyses for Drug Substance (DS), Drug Product (DP), stability studies, and protocol-based samples. Technical Expertise: Proficient in handling High-Performance Liquid Chromatography (HPLC) instruments, including Reverse Phase HPLC (RP-HPLC). Experience with Laboratory Information Management Systems (LIMS). Skilled in using chromatography data systems such as Chromeleon and Empower 3. Familiarity with Cation Exchange Chromatography (CEX) techniques. Qualifications: Master’s degree in Chemistry or a relevant field. Minimum of [Insert Number] years of experience in a pharmaceutical quality control laboratory. Strong understanding of cGMP, GLP, and regulatory requirements. Excellent analytical and problem-solving skills. Effective communication and teamwork abilities. Show more Show less

We're Hiring: Senior Executive / Assistant Manager - MSAT We are hiring multiple roles in Manufacturing Science and Technology (MSAT) group – Drug Product and Drug Substance 📍 Location: Chakan, Pune 📅 Experience: 5–15 years | Function: Manufacturing Science & Technology (MSAT) Are you passionate about driving innovation in biopharmaceutical manufacturing? Join Enzene Biosciences as a key member of our MSAT team—where science meets execution. What You’ll Do: 🔹 Act as the technical SME representing MSAT on cross-functional project teams 🔹 Lead change controls, deviations, and CAPAs as a change agent 🔹 Drive New Product Introduction (NPI) from checklist to batch execution 🔹 Prepare and execute PPQ/validation protocols and reports 🔹 Support CMC documentation and regulatory filings 🔹 Analyze and present process performance data 🔹 Conduct facility fit and process risk assessments 🔹 Coordinate equipment qualification activities 🔹 Act as the link between R&D / PD and manufacturing What You Bring: ✔ 5–15 years in MSAT with exposure to upstream, downstream, and/or drug product ✔ Experience in tech transfer, process validation, and regulatory documentation ✔ Strong understanding of GMP and regulatory frameworks ✔ A collaborative mindset and data-driven approach Why Enzene? At Enzene, we believe in Innovation, Respect, Candor, Excellence, Entrepreneurship, and Integrity. You’ll be part of a high-impact team working at the cutting edge of biologics manufacturing. Show more Show less