Role & responsibilities Technology transfer and scale-up activities at external/Third-party manufacturing/CMO sites. Coordinate and execute along with CMOs/internal teams for feasibility trials and commercial production. Evaluate & assure the equipment for capacity and process suitability at manufacturing site. Prepare and review documentation for feasibility/Trial batches, scale-up, exhibit /validation batches, and for commercial production. Plan, execute and monitor exhibit /validation batches for regulated markets at CMO/Third party manufacturing sites Ensure timely execution and readiness of CMOs for product transfers, validations and commercial Production. Troubleshoot technical issues at external manufacturing locations/CMOs and ensure smooth operations. Support regulatory documentation and compliance, especially for EU-regulated markets. Preferred candidate profile Experience in Tech Transfer, MS&T (Manufacturing Science and Technology transfer), and working with external manufacturing units/CMO. Process optimization and developmentfrom lab scale to commercial-scale batches. Strong knowledge in formulation and manufacturing of oral solid dosage forms (tablets/capsules). Familiarity with scale-up, validation, exhibit batches, and regulatory submissions. Experience in packaging will be added advantage Experience with European regulatory requirements will be a strong advantage. Project Management skills (planning, coordination, execution) Strong Communication, coordination, and problem-solving skills.
Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing/control processes at suppliers/contractors. Cooperates in reviewing annual Product Quality Review reports for products manufactured for Krka as per contract. Follows Indian legislation related to production of intermediates, active ingredients and finished products, and makes a comparison with the legislation of target markets. Acts in accordance with guidelines and instructions from Quality Management at Krka. Implements legislation requirements specific for the area of work. Manages documentation from their area of work. Follows trends, implements measures and prepares periodical reports for the area of work. Other tasks delegated by Krka Quality Management in accordance with employee's qualifications and the needs of the working process. Responsibilities for correct, professional and timely performance of tasks; for complying with legislation that applies for the manufacture of pharmaceuticals and active ingredients; for quality and timely preparation of reports; Knowledge required: - General knowledge of regulatory requirements and standards in the pharmaceutical industry for EU - Good knowledge of pharmaceutical manufacturing procedures and good manufacturing practice. - Knowledge regarding handling of deviation, complaints and changes - Good communication skills for effective collaboration with other team members and contract manufacturers - Reliability and accuracy when reviewing documentation. - Proficiency in English language - ISO 9001 standard;
Role & responsibilities Manage end-to end supply chain operations of OSD, including material planning, inventory control and co-ordination for dispatches. Co-ordinate between CMOs and HQ teams ( Planning, sourcing, and logistics) to ensure production plans are aligned and timelines are met. Arrange and track material supplies to CMOs to ensure timely availability. Ensure on-time dispatches of FDF ( Finished product Dosage Forms) with correct documentation. Monitor CMOs and logistic performance Support supply chain risk mitigation, alternate sourcing, and supply continuity planning. Regularly visits to CMOs to resolve issues related to planning, materials or logistics and ensure the smooth coordination Maintain open and continuous communication with CMO Operations, Procurement and Purchase team for product supply. Prepare Quarterly rolling plan in collaboration with CMO and HQ Planning team Preferred candidate profile Candidates with Experience in the field of Pharmaceutical supply chain and logistics only will be considered Strong Knowledge of Contract Manufacturing Organization (CMO) coordination , PPIC, and international logistics. Familiarity with GDP, GMP and EU export documentations . Excellent communication and coordination skills Manage and mentor a small team responsible for planning, material coordination and logistic follow up. OSD Production knowledge needed Knowledge in Pharma Packaging material and SKU's Experience working for EU Markets Sound knowledge of Production planning with External Manufacturing / CMO's
Job Purpose: The Regulatory Affairs and Licenses Manager is responsible for managing all activities related to obtaining licenses for pharmaceutical products, including approved, unapproved, and narcotic drugs. The role ensures compliance with national and regional regulations, with a particular focus on the legal requirements specific to Andhra Pradesh and Telangana. Experience and Responsibilities Strong working knowledge of CDSCO regulations and local state drug control offices. Familiar with Documentation requirements specific to different drug categories (approved and unapproved and narcotics) Proven experience in submitting and tracking license applications for approved, unapproved, and narcotic drugs. Key Competencies: 1. Attention to detail and documentation accuracy 2. Problem-solving regulatory foresight 3. Deadline and process-oriented mindset 4. Professionalism in dealing with government authorities
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