Production Manager (WHO, Geneva and PICS experience) Orbit Pharma

7.0 - 12.0 years

7 - 17 Lacs

Ahmedabad

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Job Summary: We are looking for an experienced Production Manager specializing in External Preparations (ointments, creams, gels, lotions, topical solutions, etc.) and Liquid filling line to manage and optimize pharmaceutical production activities. The successful candidate will have proven experience operating under WHO GMP, PICS GMP & EU GMP and will be responsible for ensuring high standards of quality, compliance, and efficiency in product manufacturing. Key Responsibilities: • Production Manager for oversees the manufacturing processes related to external preparation formulations & Liquid filling line. • Production Planning & Execution Develop and implement production schedules to meet demand while ensuring efficiency. • Compliance & Quality Assurance – Ensure adherence to GMP, WHO, and EU GMP regulatory guidelines for external preparations / Liquid filling. • Process Optimization – Improve manufacturing processes for better yield, consistency, and cost-effectiveness. • Equipment & Facility Management – Oversee the maintenance and validation of equipment used in manufacturing and packing. • Documentation & Reporting – Maintain batch records, SOP, and Logbook for manufacturing and packing line. • Troubleshooting & Problem-Solving – Address production issues, deviations, and implement CAPAs as needed. • Oversee warehouse operations, including inventory management and logistics. • Maintain accurate records of inventory and warehouse activities. • Co-ordinate with engineering teams in designing, developing, and maintaining systems or products. • Coordinate with Quality Assurance, Quality Control, Engineering, and Warehouse teams to ensure seamless operations. • Ensure equipment is properly maintained, calibrated, and qualified; plan preventive maintenance schedules in collaboration with engineering. Qualifications & Experience: • Degree in Pharmacy, Pharmaceutical Technology or related field. • 7+ years of hands-on experience in pharmaceutical manufacturing, with 3+ years in external preparations / Liquid filling. • Strong knowledge and practical experience with WHO GMP, PICS GMP, and EU GMP regulatory requirements. • Familiarity with manufacturing equipment and technologies specific to external preparations / Liquid filling. • Experience in managing inspections/audits by international regulatory agencies. • Strong leadership, organizational, and communication skills. • Fluency in English.Role & responsibilities

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Quality manager( WHO Geneva and PICS experience) Orbit

9.0 - 14.0 years

10 - 15 Lacs

Ahmedabad

Work from Office

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

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