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    Lead Manufacturing Operations -Osd

    Syngene
    18+ years
    Not Disclosed
    Bengaluru
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Lead Manufacturing Operations - OSD
    Job Location: Biocon Park, Bengaluru
    Date: 10 Jan 2025
    Experience Required: 18+ years

    Company Overview:

    Syngene International Ltd. is a leading contract research, development, and manufacturing organization offering integrated scientific services. The company partners with global leaders in the pharmaceutical, biotechnology, and other industries to deliver high-quality, innovative solutions. Syngene’s commitment to safety, operational excellence, and compliance is at the core of all its endeavors.

    Job Purpose:

    The primary objective of this role is to ensure the highest standards of manufacturing compliance and quality for Oral Solids products (e.g., tablets, capsules, pellets, liquid-filled capsules). This includes managing regulatory audits and overseeing corrective and preventive actions (CAPA) to foster continuous improvement. The role contributes directly to Syngene's commitment to patient safety, regulatory compliance, and operational excellence in the manufacturing process.

    Key Responsibilities:

    • Manufacturing and Packaging Compliance:

      • Ensure that all oral solids manufacturing and packaging processes are audit-ready and comply with cGMP and regulatory standards (USFDA, EU, MHRA, Health Canada).

    • Quality Management System (QMS):

      • Manage and review QMS documentation, including change controls, deviations, investigations, CAPA, OOS, OOT, customer complaints, APQR, and validation protocols.
      • Ensure adherence to QMS requirements in all manufacturing processes and activities.

    • Process Improvement and Cost Management:

      • Lead projects on cost savings and process improvements within the development and manufacturing processes.
      • Support the management of annual CAPEX and operational requirements to ensure cost-effective operations.

    • Facility and Equipment Management:

      • Review facility capacity and equipment feasibility for rolling plans and new product requirements.
      • Initiate proposals for new equipment procurement, facility upgrades, and expansion.

    • Documentation and Compliance:

      • Oversee the review of URS, DQ, IQ, OQ, and PQ of equipment and instruments.
      • Ensure that documentation meets all regulatory and quality standards.

    • Cross-functional Coordination:

      • Coordinate with cross-functional teams to ensure the facility meets compliance standards and production targets.

    • Safety and Compliance:

      • Ensure adherence to safety protocols and the achievement of safety goals in line with Syngene’s quality and safety standards.
      • Participate in safety audits and ensure timely completion of required training related to safety and data integrity.

    Leadership Capabilities:

    • Project Management:

      • Capable of managing multiple projects simultaneously with a focus on compliance and continuous improvement.

    • Team Leadership:

      • Lead and motivate cross-functional teams, ensuring effective collaboration and accountability.

    • Problem-Solving:

      • Strong problem-solving skills to address and resolve compliance issues swiftly and effectively.

    • Performance Drive:

      • Drive team performance against established outcomes, ensuring high standards and operational excellence.

    Syngene Values:

    • Excellence
    • Integrity
    • Professionalism

    Specific Requirements for this Role:

    • Experience:

      • Over 18 years of experience in manufacturing operations, particularly in oral solids. Experience with injectables is a plus.

    • Regulatory Experience:

      • Experience with regulatory audits from agencies such as FDA, EMEA, and Health Canada.
      • Participation in self-inspections, internal quality audits, and management review meetings.

    • Technical Expertise:

      • Strong expertise in oral solids product manufacturing and process troubleshooting.
      • Experience in conducting investigations, CAPA management, and analyzing compliance data.
      • Knowledge of QRM assessments, BMR, BPR, and artwork review.

    • Educational Qualifications:

      • Postgraduate degree in Pharmacy.

    Equal Opportunity Employer:

    Syngene is committed to providing equal employment opportunities to all individuals, regardless of age, race, color, national origin, disability, religion, gender, sexual orientation, or any other characteristic protected by applicable law. Syngene also provides reasonable accommodations for qualified individuals with disabilities.

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