Deputy Manager | Manager - Production QMS - OSD Formulations

Job Title: Production OSD QMS Specialist - Deputy Manager / Manager - MSN Formulations

Job Overview:

We are looking for a highly skilled Production OSD QMS Specialist to manage the Quality Management System (QMS) in the production of oral solid dosage (OSD) forms. This role involves ensuring error-free documentation, thorough investigations of Out-of-trend (OOT) and Out-of-specification (OOS)events, and supporting international product launches through robust documentation management.

Key Responsibilities:

• QMS Management: Ensure all Quality Management System documentation is maintained and managed without errors.
• OOT/OOS Investigations: Lead and execute detailed investigations into OOT and OOS events, including comprehensive data analysis and preparation of technical reports.
• Regulatory Inspections: Act as the point of contact during internal and external inspections, explaining investigations and corrective actions.
• International Customer Interaction: Manage and support international customer documentation requirements for product launches, ensuring compliance with all regulatory and customer specifications.
• Documentation Accuracy: Prepare and review documents related to product quality, regulatory compliance, and customer requirements, ensuring all are accurate and up to date.

Qualifications:

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field (Master's preferred).
• 10-15 years of experience in QMS and production-related roles within the pharmaceutical industry, specifically OSD.
• In-depth knowledge of GMP and regulatory standards (FDA, EMA).
• Proven experience in OOT/OOS investigations and technical report writing.
• Strong communication skills, with the ability to interact with international customers and regulatory bodies.
• Detail-oriented with strong analytical and problem-solving abilities.