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Post: Assistant Manager - ESIQ
Job Description
- To ensure that all manufacturing, packing operations carried out at external manufacturing sites are in compliance to current good manufacturing practices.
- To ensure that the testing carried out at the External Manufacturing Location laboratories are in compliance to Good Laboratory Practices.
- To ensure that quality systems are established and followed in compliance to J&J quality systems policies at the Corporate and External Manufacturing Site.
- To ensure that all documents are created, revised, identified, approved, issued, distributed, retrieved and disposed as per Good Documentation practices complying to 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, SOPs, Validation documents, like URS, Qualification protocols, Process Validation Protocols, Cleaning validation protocols and Stability protocols.
- Participating in Identification, Screening of various new contract manufacturing sites based on business requirements which can meet the J&J requirements based on their capabilities and Risk assessment done on facility overview, manpower, systems, experience etc. through onsite visits and pre-audits as and when required
- To ensure that all Changes at External manufacturing sites related to J&J products and Critical systems are managed through Change Control system and assessed for its impact, scientifically executed and closed in compliance the Regulatory and Corporate requirements.
- To ensure that a proper Change Control System is in place at J&J corporate to handle all changes which have regulatory or validation Impact. To ensure that the change control procedure is updated as per J&J corporate procedure and all concerned are trained on the procedure.
- 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 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 future.
- 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 finding 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 raw and packaging materials analysis, bulk and finished product analysis reports, microbial raw data and results, batch manufacturing and packaging records and releasing product to dispatch..
Job Responsibilities
- Review of stability analysis 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 location to fulfil regulatory and J&J guidelines and requirements.
- To prepare response to be submitted to health authority.
- Co-ordination to EHS section about EHS point and follow-up and rectification of same to comply EHS requirements.
- To ensure that a CAPA plan is designed, agreed and approved to comply the findings noticed during any Regulatory audit.
- To ensure that the CAPA is implemented timely, tracked for its completion, monitor its effectiveness, modify if required and close it.
- To ensure that all artworks are created and revised as per procedure. To ensure that proper Change control system is followed to revise and create the artworks.
- 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.
- Delegate the batch review to EM as per SOP on Batch review delegation. In absence of delegation, review of full batch documents.
- To designing CAPA in association with the EM to mitigate the market complaints.Trending of market complaint and review of the trends to take appropriate CAPA.
- To ensure that all critical product issued are immediately escalated as per corporate procedure, investigated and resolved to ensure business continuity
- To train all the concerned stakeholders like EM, QC, QA and production and other allied persons on the critical quality procedures.
- To conduct need base training programs on current technical and regulatory updates to EM employees
- To Support the technology transfer, validation work and launch for new products at External Manufacturers as per J&J Guidelines.
- To Design and Conducting Process Validation, Cleaning Validation scheduling, Validation for formulations like tablets etc, Hold time study of products and equipment.
- To Collect, Compile the Trend data and preparation of APR and correlation of APR trends with the product validation status.
- To report the Quality metrics monthly- related with EM site to Corporate QA
- To support R&D activity, related with new product or any vendor development trials at the site.
- Vendor development raw material analysis and related trials at site to take decision for commercial supply and vendor approval.
- Provide method of analysis and reference standard to FDA lab as and when requirements comes.
- Co-ordinate and arrangements of market samples for market brand study and analysis
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Qualifications
1. Minimum Bachelor's Degree Required.
2. A minimum of 6-10 years in Pharmaceutical/Medical Device/Biotech is required. Experience in drugs, biologics and medical devices are essential to success.
3. Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required. Experience in presenting issues to all levels of the organization is required.
4. Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers is required. Demonstrated experience with all dosage forms is preferred.
5. Experience investigating customer Product Quality Complaints is preferred.
6. Proficiency in computer applications such as the MS Office suite is preferred.
7. Demonstrates refined skills in the following Global Leadership areas: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Results and Performance Driven.
8. Ability to travel a minimum of 30% is required.
Additional Information:
Qualification: Bachelor's Degree
Location: Maharashtra-Greater Mumbai
Functional Area: Quality (Generalist)
Industry Type: Pharma/Biotech/Clinical Research
End Date: 20th May, 2017
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