Sanjay N.
Quality Director (GMP/GDP Consultant - for various Pharma & Biotech clients) at inglasia pharma solutions- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Andrew Joy
Sanjay has provided extensive and expert advice for QA/GMP/GDP operations. His support has been greatly appreciated in providing; comprehensive assistance in a GMP/GDP supplier audit program; providing experienced auditors, timely reporting and completion. Sanjay has been very engaging, pragmatic with a professional and support active approach. I would recommend Sanjay and Inglasia for continued professional QA expertise in a GxP environment.
Angelica O.
Sanjay is a quality professional with broad knowledge and experience who provided solid guidance and support in quality assurance topics. Besides sharing his excellent technical knowledge and practical cases, he displayed great communication skills. Without any doubt, I would recommend Sanjay to any organization or any professional looking for any QA/GMP consultancy.
Stewart Manegold
Sanjay provided excellent GMP/QA support during the recommissioning of a GMP manufacturing site that had previously been closed down. Coordinating all revalidation activities at the site and preparation of QA procedures and training activities of QA and production staff until such time as there was sufficient resource within the QA department to hand over these activities. Sanjay and his team were both capable technically and able to get alongside the staff on site in a professional but friendly manner.
Andrew Joy
Sanjay has provided extensive and expert advice for QA/GMP/GDP operations. His support has been greatly appreciated in providing; comprehensive assistance in a GMP/GDP supplier audit program; providing experienced auditors, timely reporting and completion. Sanjay has been very engaging, pragmatic with a professional and support active approach. I would recommend Sanjay and Inglasia for continued professional QA expertise in a GxP environment.
Angelica O.
Sanjay is a quality professional with broad knowledge and experience who provided solid guidance and support in quality assurance topics. Besides sharing his excellent technical knowledge and practical cases, he displayed great communication skills. Without any doubt, I would recommend Sanjay to any organization or any professional looking for any QA/GMP consultancy.
Stewart Manegold
Sanjay provided excellent GMP/QA support during the recommissioning of a GMP manufacturing site that had previously been closed down. Coordinating all revalidation activities at the site and preparation of QA procedures and training activities of QA and production staff until such time as there was sufficient resource within the QA department to hand over these activities. Sanjay and his team were both capable technically and able to get alongside the staff on site in a professional but friendly manner.
Andrew Joy
Sanjay has provided extensive and expert advice for QA/GMP/GDP operations. His support has been greatly appreciated in providing; comprehensive assistance in a GMP/GDP supplier audit program; providing experienced auditors, timely reporting and completion. Sanjay has been very engaging, pragmatic with a professional and support active approach. I would recommend Sanjay and Inglasia for continued professional QA expertise in a GxP environment.
Angelica O.
Sanjay is a quality professional with broad knowledge and experience who provided solid guidance and support in quality assurance topics. Besides sharing his excellent technical knowledge and practical cases, he displayed great communication skills. Without any doubt, I would recommend Sanjay to any organization or any professional looking for any QA/GMP consultancy.
Stewart Manegold
Sanjay provided excellent GMP/QA support during the recommissioning of a GMP manufacturing site that had previously been closed down. Coordinating all revalidation activities at the site and preparation of QA procedures and training activities of QA and production staff until such time as there was sufficient resource within the QA department to hand over these activities. Sanjay and his team were both capable technically and able to get alongside the staff on site in a professional but friendly manner.
Andrew Joy
Sanjay has provided extensive and expert advice for QA/GMP/GDP operations. His support has been greatly appreciated in providing; comprehensive assistance in a GMP/GDP supplier audit program; providing experienced auditors, timely reporting and completion. Sanjay has been very engaging, pragmatic with a professional and support active approach. I would recommend Sanjay and Inglasia for continued professional QA expertise in a GxP environment.
Angelica O.
Sanjay is a quality professional with broad knowledge and experience who provided solid guidance and support in quality assurance topics. Besides sharing his excellent technical knowledge and practical cases, he displayed great communication skills. Without any doubt, I would recommend Sanjay to any organization or any professional looking for any QA/GMP consultancy.
Stewart Manegold
Sanjay provided excellent GMP/QA support during the recommissioning of a GMP manufacturing site that had previously been closed down. Coordinating all revalidation activities at the site and preparation of QA procedures and training activities of QA and production staff until such time as there was sufficient resource within the QA department to hand over these activities. Sanjay and his team were both capable technically and able to get alongside the staff on site in a professional but friendly manner.
Credentials
-
Fellow of the Royal Society of Chemistry
Royal Society of ChemistryMar, 2021- Oct, 2024
Experience
-
inglasia pharma solutions
-
United Kingdom
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Quality Director (GMP/GDP Consultant - for various Pharma & Biotech clients)
-
Sep 2012 - Present
Provision of GDP, GMP related consultancy and training services. Advisor to private investors on the acquisition and setup of Pharmaceutical manufacturers and distributors Interim Quality Director, Head of Quality and Senior QA Specialist titled roles responsible for: Managing Global and local QA department Personnel and Quality System Conduct GMP audits (Sterile, solid dose, liquids and API manufacturing) Conduct GDP audits (Distributors, Wholesalers, Affiliate offices, carriers and brokers) QA validation review & approval of ATIMP/ATMP manufacturing equipment and process Support with acquiring EU GMP certification. Support with acquire Wholesale Dealer Authorisation. Inspection readiness and remediation. Supply Chain Mapping Strategy and Risk Assessment Named as Responsible Person on Wholesale Dealer Authorisation Implementing Pharmaceutical Quality Systems in ATMP, sterile, solid dose and liquids manufacturing sites to meet MHRA/FDA regulatory requirements. Implementing Pharmaceutical Quality Systems at distributor sites. Support in completing User Requirement Specification (URS), design, qualification and validation and commissioning of R&D, commercial manufacturing and distribution facilities. Providing GMP/GDP training.
-
-
-
Gilead Sciences
-
United States
-
Biotechnology Research
-
700 & Above Employee
-
Sr. Manager, Corporate Quality
-
Feb 2012 - Sep 2012
Managing audits of Gilead Affiliates and contracted warehouses in Europe, Middle East and Australasia (EMEA). Supporting Affiliates in preparation for local GDP Regulatory Inspections. Performing due diligence audits of potential new contract warehouses and submitting recommendations as part of the selection process. Conducting GDP training to Affiliates and the Gilead manufacturing facility and distribution warehouses. Auditing Gilead global manufacturing facilities to EU GMP standards.
-
-
-
-
GMP/GDP Manager
-
Jul 2010 - Feb 2012
Reporting to US Senior GMP/GDP Manager. Responsibilities include: Implementing a robust QMS for managing all UK and European storage and distribution operations. Manage comprehensive GMP/GDP compliance in Europe, for R&D and commercial. Manage direct report and track objectives and performance. Planning and conducting external vendor audits. Drafting, implementing and maintaining Technical Agreements with vendors. Review master assembly specs and completed packaging records prior to QP approval. Pepare and maintain SOPs and systems required to comply with regulatory requirements. Manage product complaints and recalls from the European market.
-
-
-
sanofi-aventis
-
France
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
QA Manager
-
Dec 2005 - Jul 2010
Reporting to UK Head of Quality, and acting as designate UK Affiliate Quality Officer for Corporate sanofi-aventis. Role involved: Releasing products to market from the UK distribution centre. I was often delegated duties of the Responsible Person. Understanding the regulatory authority requirements for marketed and clinical trial medicines and devices. Worked with UK Regulatory department to ensure variations implemented in a timely manner for legal compliance and patient safety. Initiated and maintained technical agreements with subcontractor and company sites for cGMP, GCP and GDP activities. Managing a team handling product technical complaints on UK marketed and clinical trial medicines and devices. Identifying improvements to products and services to patient. Implemented the internal and external audit programme and auditing of subcontractors to cGMP, GCP and GDP standards. Raising the awareness of cGMP, GCP and GDP within the Head Office by providing training on quality SOPs. Working closely with external customers, DOH, MHRA/DMRC, EMA and corporate quality colleaugues on identifying out of stock situations, ensuring that counterfeit products are investigated and assist with identification of defective medicines and devices within the UK and European market. Led numerous projects in process improvement and communicating to all departments the importance of maintaining consistent quality standards through procedures and validated systems.
-
-
-
Generics UK Limited
-
United Kingdom
-
Pharmaceutical Manufacturing
-
Senior QC Officer
-
Jul 2004 - Dec 2005
Managed team checking batch records; Worked cross-functionally resolving deviations and out of specifications prior to QP review; Improved efficiency of existing QMS; Performed internal and external audits; Team player in gaining MRA for the site. Customer certificate generation; Solving external customer queries. Checking and approving method validation work. Managed team checking batch records; Worked cross-functionally resolving deviations and out of specifications prior to QP review; Improved efficiency of existing QMS; Performed internal and external audits; Team player in gaining MRA for the site. Customer certificate generation; Solving external customer queries. Checking and approving method validation work.
-
-
-
Lanes Health
-
United Kingdom
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Compliance Officer
-
Aug 2002 - May 2004
Performed internal/external cGMP and themed audits; Compliance review of manufacturing documents prior to QP release. Designed and implemented qualification/validation studies; Performed root causes/corrective action investigations; Co-ordinated, controlled and performed cleaning validation activities; Maintenance of QMS documentation. Performed internal/external cGMP and themed audits; Compliance review of manufacturing documents prior to QP release. Designed and implemented qualification/validation studies; Performed root causes/corrective action investigations; Co-ordinated, controlled and performed cleaning validation activities; Maintenance of QMS documentation.
-
-
-
Novartis
-
Switzerland
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
QC Analyst
-
Jul 1998 - Jul 2002
QC laboratory work; Analytical testing; Stability testing; Wrote SOPs; Reviewed testing methods; In charge of service contracts; Worked on transfer projects. QC laboratory work; Analytical testing; Stability testing; Wrote SOPs; Reviewed testing methods; In charge of service contracts; Worked on transfer projects.
-
-
Education
-
1994 - 1998
University of Surrey
BSc, Chemistry -
Trinity School
Community
