Quality Manager Pharmaceutical Manufacturing Department: Quality Specialist Reports to: Director Job Summary: We are seeking a highly competent and detail-oriented Quality Manager to lead the Quality Assurance and Quality control functions at our pharmaceutical manufacturing site. The successful candidate will bring deep knowledge of WHO GMP, PICS standards, and EU GMP regulatory expectations, ensuring full compliance and continuous improvement of the Quality Management System (QMS). Key Responsibilities: • Lead, manage, and continuously improve the Quality Management System (QMS) to ensure full compliance with WHO, PICS, and EU GMP regulatory requirements. • Oversee GMP compliance, including batch record review, deviation management, CAPAs, change control, product release, OOS, OOT and risk assessments. • Act as the site representative during inspections and audits (WHO PQ, EU GMP, PICS, clients), including preparation, hosting, and follow-up. • Supervise and mentor QA / QC teams responsible for documentation control, training, and GMP compliance. • Develop and implement cleaning validation, Process validation, Equipment qualification and utility qualification activity. • Review and approve critical quality documents such as SOPs, protocols, reports, and validation master plans. • Oversee the vendor qualification and quality agreements with external suppliers, service providers, and contract manufacturers. • Lead internal audits and support continuous quality improvement initiatives. • Collaborating with cross-functional teams to ensure quality throughout the product lifecycle. • Developing and implementing quality control systems. • Monitoring performance of quality control processes. • Analyzing quality data to identify areas for improvement. Qualifications & Experience: • Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or related life sciences field. • Minimum of 8 years of pharmaceutical quality experience, with 3+ years in a managerial or leadership role. • In-depth knowledge of WHO GMP, PICS guidelines, and European regulatory requirements. • Strong experience leading audits/inspections from international authorities (e.g., WHO, PICS, EU) • Excellent analytical, leadership, and interpersonal skills. • Fluent in English
Position: AM_ ADL Key Requirements: Conducting in-depth Literature and patent search and making formulation development plan for Solid oral and Liquid oral formulations Develop new formulation concepts, assists in the development of project plans, business analysis and feasibility assessments. Develop experimental programs, work plan and prioritize assignments to meet project objectives within defined timelines Review and analysis of experimental data and design of further experiments. Monitoring of stability studies and Data interpretation Formula and process optimization studies - Discussion/design, review and monitoring of PET trials, pH Establishment Trials and PDR Trials Identify and manage the potential risks within projects in a timely fashion Arrange and management inventories (RM, PM, RLD etc.) required for projects. Conducting root cause analysis and trouble shooting Co-ordinate with cross functional teams for smooth flow of projects Review of technical documents like QnQ, Draft specifications, PDR report and finalization, MFR, PVP, HTSP etc. Monitoring and providing technical support for scale up and validation batches Desired qualifications: M. Pharma Desired skills: Proactive self-starter who is comfortable working independently in a fast-paced environment while maintaining attention to detail Hands on experience in formulation development of solid orals and liquid orals for regulated markets Knowledge on QbD and DoE concepts Knowledge on Regulatory guidelines for USA/Europe/ROW markets Trouble shooting and Root cause analysis skills
QA Executive Pharmaceutical ManufacturingDepartment: Quality Assurance Reports To: QA Manager Location: Ahmedabad Employment Type: Full-Time Job Summary: The QA Executive plays a critical role in ensuring that all pharmaceutical products are manufactured in compliance with cGMP guidelines, regulatory requirements, and internal quality standards. The role involves overseeing production processes, documentation, audits, deviation handling, and supporting continuous quality improvements to ensure patient safety and product efficacy. Key Responsibilities: Ensure compliance with GMP (Good Manufacturing Practices) and applicable regulatory requirements (e.g., USFDA, MHRA, WHO, EU, TGA ). Review and approve manufacturing and packaging batch records, logbooks, and equipment qualification protocols. Monitor production and quality control activities to ensure alignment with SOPs and regulatory standards. Conduct line clearance , in-process quality checks, and batch release documentation. Manage and investigate deviations, change controls, CAPA, OOS, and OOT cases. Participate in internal audits and support regulatory inspections by preparing documentation and responding to queries. Maintain QA-related documentation including SOPs, quality manuals, and validation reports . Review and approve Standard Operating Procedures (SOPs) and ensure their periodic revision and compliance. Participate in vendor audits and qualification processes for raw materials and packaging materials. Train staff on quality procedures, GMP guidelines, and hygiene practices. Required Qualifications: Masters degree in Pharmacy ( M.Pharm - QA) or related life sciences. Sound knowledge of GMP, ICH guidelines, regulatory compliance , and pharmaceutical documentation. Familiarity with QMS systems and electronic documentation tools (e.g., TrackWise, MasterControl). Good understanding of equipment validation, cleaning validation, and process validation principles. Key Skills: Strong analytical and documentation skills Attention to detail and accuracy Effective communication and teamwork Problem-solving and root cause analysis Knowledge of regulatory inspection protocols