Sankar Boobalakrishnan Email & Phone Number

Bengaluru, Karnataka, India

'Customer Advocacy' @ValGenesis would focus on building customer relationship management, trust and satisfaction through high quality customer service, dedicated expert advice and ensuring relentless support in resolving customer feedbacks in a timely and effective manner. CA team would be the liaison between our customers and ValGenesis internal team / organization to ensure our customers get their desired outcome while using our ValGenesis products - be it a roll out / implementation, enhancements, specific operational / regulatory advise and VG business offerings to name a few - that can hugely benefit our customers. This evolving journey would be focused towards consistently driving our internal efforts to bring substantial value addition and success to our customers in all our engagements / collaborations - at every stage of the (customer) life cycle.

Bengaluru, Karnataka, India

I am an experienced Quality Executive with over 20 years’ experience in the Pharma, Biopharma & Medical Devices (MD) industry [non-sterile (OSD), sterile / aseptic manufacturing (DS & DP) & MD development, clinical & commercial manufacturing. As an independent life sciences consultant, I passionately support my Pharma, Biopharma & MD industries clients by providing exhaustive suite of support and cost effective implementation services such as New Manufacturing facility design & operational reviews (Concept to Commercialisation, cGMP, MEP flows, area classification, contamination control strategy, Risk identification and design controls, Hazop etc.,) and establishment / support towards simplified & yet compliant Commissioning & Qualification & Validation (CQ&V) approach / program for a successful & efficient project delivery. My offerings includes but not limited to CQV support, value added Q&V test documentation and SOP developments (drafting) & independent reviews, CSV, quality system development for new / established site(s) - to ensure they are simple, effective & comply to the current regulatory standards and industry best practices. Leveraging my Operational Quality & Engineering Quality experience, my clients benefit through compliance consultation, Engineering / metrology [Calibration, PM / AMC & Breakdown] related optimisation & resource optimisation projects for cost effective, sustainable & successful results. I have extensive experience & overseen multiple regulatory audits from highly regulated markets [US FDA, EMA (ANSM, HPRA to name few), Health Canada, MoH Russia, PMDA, ANVISA, SFDA, TGA & other PIC/S inspectorates & DCGI]. Leveraging my significant audit experience & being an IRCA & CQI certified Lead Auditor, my scope of works extends into documented Gap & Risk assessments, 3rd party audits, Audit readiness&remediation (CAPA), cGMP training etc.,Contact me for a value added, compliant and yet simplified solutions for your challenges.

Bengaluru, Karnataka, India

Senior leadership team (SLT) and a member of Quality Leadership team (QLT), reporting into “Chief Quality Officer'. Responsible for overall quality assurance across multiple sites (India and Malaysia) for both biological products manufacturing (Bio-similars microbial and mammalian based products, insulin and analogues) and small molecules manufacturing facilities for drug product and drug substances. As a Global head, accountable for QA Engineering department in developing, implementing the robust science & risk-based C&Q program for Equipment / Facility / utility / Systems (including IT / automation systems [CSV]) and provide QA oversight in maintaining routine state of control globally (across Biocon sites) for multiple manufacturing facilities across Biocon Biologics to meet or exceed international regulatory standards & drive ‘Right First Time’ effort. This includes large scale Green Field projects and brown field projects, in-line with best industry practices & current regulatory expectations and state of control.First in-kind and successful implementation of eVLMS (by Valgenesis) across BBL sites (Bangalore & Malaysia) for C&Q life cycle as part of digital transformation of C&Q process. Plans, support and implement Strategic plans – both organisation & functional deliverables - and successful roll outs to support organisation towards its digital transformation journey.

Hong Kong

Jacobson Pharma Group (JPG) is a leading Pharma group in providing pharmaceutical products (Sterile opthalmic / Non-sterile OSD & OLD forms) and Chinese medicines to Greater China region through its more than five (5) of its Business Units (BU) / affiliates.1. Group Level Compliance Audit & Validation Leader, responsible for leading GMP compliance audit (Corporate / Group) and validation team.2. Overseeing the planning, establishing and implementing programs for - cGMP and GDP [distribution] compliance internal auditing (Corporate / Group Audits) of Pharmaceutical manufacturing and warehousing and suplly chain activities (including customer complaints, recall etc.,) within BU / affiliates to assess compliance with all pertinent regulations. - Validation of Pharmaceutical systems and processes including CSV - Risk assessment programs within the pharma group to comply with cGMP and GDP and PIC/S requirements and other relevant international regulatory standards. - Technical Training for group staffs4. Communicates and interacts with HK GMP inspection and regulatory authorities on technical aspects for the entire Pharma Group.5. Ensure staff quality, safety and technical training programs are adequate and continue to enhance the relevant programs as necessary.6. To establish and monitor performance index, mechanism and tracking system that enable review and continuous improvement in QMS system effectiveness of each subsidiary. 7. Participate in external audits (HK Health Authorities) as SME & render support to BU in technical / validation issues & remediation etc.8. Leading a team of expereinced professionals for Group Compliance Audit and Validation within the group and associated business units.

Hong Kong

Group Level Validation Leader, responsible for developing, implementing and maintaining overall Validation program for multiple business units (affiliates) within the Pharma group to meet or exceed PIC/S & other relevant international regulatory standards. Jacobson Pharma Group (JPG) is a leading Pharma group in providing pharmaceutical products (non-sterile / sterile OSD & OLD forms) and Chinese medicines to Greater China region through its more than five (5) of its affiliates.1. Develop & implement robust science & risk based C&Q & validation program for Processes, Products, Equipment, Systems (including CSV), Utilities & Facilities in line with best industry practices & current regulatory expectations & PIC/S standard. 2. Provide oversight for the all BUs & its validation team to device & implement reliable Q&V strategy - VMP, RA & TM, PV (Raw mat to pack - end to end) / CV & other simulation including Aseptic & Media Fill Process etc., 3. Development of validation teams - both Group & affiliates level - through relevant validation training & personnel qualification program; Engagement of contract resources&consultation as required.4. Programs to ensure on-going validation maintenance via periodic review, re-qualification / revalidation & change related IA with an ultimate goal of CPV. 5. Conduct group level (internal) audits&perform GA; CAPA / improvement initiatives in line with QMS requirements. 6. Commercialisation partnership with R&D; ensure robust scale-up7. Develop group level procedures (internal guidance) to standardise C&Q/V practices across BUs to drive RFT.8. Collaborate with cross functional teams at Group & BU levels - define C&Q/V interface for new projects (new GMP facility build) & revamp projects (as part of PIC/S up gradation) & ensure val resources to support business initiatives. 9. Participate in external audits (Health Authorities) as SME & render support to BU in technical / validation issues & remediation etc.

Singapore

1. Responsible for Facility, Equipment and process validation of sterile manufacturing facility. 2. Lead a team of validation engineers and external resources (contracted in to support validation activities as required).3. Develop validation and revalidation project plans; project management responsibilities for ensuring new systems are implemented within defined timelines. 3. Conduct periodical risk assessment for manufacturing and validation systems / programs to ensure relevant corporate and regulatory guidelines are met. 4. Provide technical assessment, review and approval of changes and discrepancies. 5. Support periodic internal audits, pre approval inspection readiness and subsequent product launch.

Singapore

1. Lead technology transfers of various secondary pharmaceutical (drug manufacturing) products and process & cleaning validation activities in multi product facility. 2. Lead start up, commissioning, IOQ and Performance Qualification of drug manufacturing equipments / facility (includes High Shear Granulator, fluidized bed dryer and compression machines). 3. Responsible for technical support of Single & Bi-layer compression products and continuous improvement using relevant LSS (Lean Six Sigma) tools. Prepare and execute validation protocols and consolidation of technical reports. 4. SME for product and process related deviation & investigations and technical assessment; product related customer complaints investigation and impact assessment. 5. SME for internal / external regulatory audit and provide technical support.

Singapore

1. Shift lead for the Manufacturing of API & secondary pharmaceutical products (drug manufacturing). 2. Managing production team, schedule preparation, planning and ensure that the production timelines are met. 3. Inventory management through organization’s ERP system and update management team through daily meeting / visual system on the production status / ensuring targets are met per schedule. 4. Responsible for shift teams training, compliance to relevant procedures and their safety. 5. Lead and involve shift team members on the deviation investigation and appropriate corrective / preventive action implementation in co-ordination with Quality / Engineering functions. 6. Lead process work flow optimization, organize and implement quick hit improvement projects (Kaizen) and effective team work. 7. Co-ordinating with cross functional teams for Technology transfer (New Product Introduction) for new product introduction and establishing relevant systems with proper risk assessment.