Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products, and services to advance the health and well-being of people. Every day, more than 130,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases, and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services, and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives and aims to empower people through disease awareness, education, and access to quality care in six therapeutic areas.
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Position: Senior Manager, External Quality Asia Pacific
Location: Hyderabad, Telangana, India
- The candidate will be responsible for the External Quality role to perform the role of quality oversight for External Manufacturing (EM) sites.
- This position will work with cross-functional teams to complete the External Manufacturer selection process and support the timely execution of relevant technology transfer processes.
- This position will also be responsible for the quality oversight and governance of the External Manufacturer (EM) quality systems/compliance for the supply chain of Vaccine / Large Molecule Direct Product Capture/Formulated Bulk, and Parenteral Drug Product through aseptic processing as well as critical raw materials /components. This is accomplished by means of on-site audits, relationship,s or other tools, in order to proactively assure the quality, compliance, and conformity of supplied materials.
GxP Compliance at External Manufacturing sites Location in India
- To ensure that all manufacturing, packing operations carried out at external manufacturing sites are in compliance with relevant J&J standards as well as current good manufacturing practices.
- To ensure that the testing carried out at the External Manufacturing Location laboratories is in compliance with Good Laboratory Practices.
- To ensure that quality systems are established and followed in compliance with J&J quality systems policies at the Corporate and External Manufacturing Site.
- Lead & participate, and follow up audits, due diligence, evaluations, and technical visits to achieve objectives listed above.
Technology Transfers/ Validations:
- To Support the technology transfer, validation activities, and launch for new products at External Manufacturers as per J&J Guidelines.
- To Review Process Validation, Equipment Qualification, Method transfer/validation, Aseptic process simulations, Cleaning Validation scheduling, etc.
- To ensure that all critical/GMP documents are created, revised, identified, approved, issued, distributed, retrieved, and disposed of as per Good Documentation practices complying with J&J corporate policies and local regulatory requirements.
- To ensure that all concerned employees are trained before the new or revised document is implemented.
- Reviewing and approving the critical documents like Master Manufacturing Records, Batch Records, Validation documents, like Process Validation Protocols, Cleaning validation protocols, and Stability protocols.
A. Change Management:
To ensure that all Changes at External Manufacturing sites related to J&J products and Critical systems are managed through the Change Control system and assessed for its impact, scientifically executed, and closed in compliance with the Regulatory and Corporate requirements.
B. Deviation /Non-Conformance Management:
- To ensure that all deviations and Non-Conformances at External manufacturing sites related to J&J products and Critical systems are suitably, scientifically, and logically handled, documented, investigated for the root cause, assessed for its impact on Product Quality and Safety.
- To ensure that appropriate corrective actions are taken to mitigate the effect of deviation or non- conformance on the Product and Preventive actions are taken to mitigate the recurrence in the future.
C. Quality Audits/Quality Reviews:
- To design a program to conduct periodic Quality Audits at External Manufacturing Sites, J&J contracted Warehouses as and when required, to ensure the compliance of systems and procedures.
- To carry routine quality rounds at the EM site, documentation reviews to ensure compliance.
- To report the audit findings to the J&J and Contractor’s Top Management and recommend appropriate Corrective and Preventive actions to close the findings.
- Review of QC documents like finished product analysis reports microbial results, batch manufacturing, and packaging records and releasing products to dispatch.
Review of stability analysis of raw data and results.
Attend on-line problems of raw and packaging materials and ensuring quality supply from suppliers.
Co-ordination of validation activity at a location to fulfill regulatory and J&J guidelines and requirements.
To prepare a response to be submitted to the health authority.
Co-ordination to EHS section about EHS point and follow-up and rectification of the same to comply with EHS requirements.
C. CAPA Management:
- To ensure that a CAPA plan is designed, agreed upon, and approved to comply with the findings noticed during any Regulatory audit.
- To ensure that the CAPA is implemented timely, tracked for its completion, monitor its effectiveness.
D. Artwork Management:
- To ensure that all artworks are created and revised as per the procedure.
- To ensure that a proper Change control system is followed to revise and create the artworks.
E. Product Release, Distribution, Storage:
- To ensure that the J&J products are manufactured and released timely as per GMP to the markets to ensure the continuous supply of the product.
- To ensure that the Products are released after complete documentation review and dispatched.
- To ensure that products are suitably stored at the J&J contracted warehouses.
- To delegate the batch review to EM as per SOP on the Batch review delegation. In absence of delegation, review of full batch documents.
- To support the necessary shipping study for products as well as samples.
F. Complaint handling:
- To design CAPA in association with the EM to mitigate the market complaints.
- Review of the trends to take appropriate CAPA.
- Critical product issue escalation/resolution & Crisis Management.
- To ensure that all critical product issues are immediately escalated as per corporate procedure, investigated and resolved to ensure business continuation train all the concerned stakeholders like EM, QC, QA, and production and other allied persons on the critical quality procedures.
- To conduct need-based training programs on current technical updates to EM employees.
G. Technology Transfers/ Validations:
- To Support the technology transfer, validation, and launch for new products at External Manufacturers as per J&J Guidelines.
- To Review Process Validation, Cleaning Validation scheduling, Validation for formulations like tablets, etc, Hold time study of products and equipment.
H. Annual Product Reviews:
- To review and approve Trend data and APR. Correlation of APR trends with the product validation status.
- To report the Quality metrics monthly- related to EM site as an input to EQ Regional Metrics.
Desired Candidate Profile:
- Technical skills and extensive knowledge of GMPs, Validation, Quality Systems, and Business Excellence.
- Some experience in External Manufacturing, Packaging validation, process/cleaning validation, and tech transfer is an advantage
- The experience of quality systems of major regulated markets is an advantage.
- Understanding the business implications regarding quality positions and decisions. Influence in Matrix management.
- Ability to quickly assimilate new technologies, perform a risk assessment, and develop action plans.
- Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
- Interpersonal skills to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in EMs and J&J.
- Business and customer focus
- Flexibility ability to handle ambiguous situations, independence, and self-sufficiency.
- Excellent communication skills.
- Fluency in English.
Qualification: Bachelor or master’s degree in science, pharmacy or equivalent education
Experience: At least 12 years of experience in a pharmaceutical and/or biotechnology environment with proven experience in QA, Biological drug substance and/or drug product, vaccine manufacturing, process engineering, QC, or R&D.
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