Qualification Board/ University Year of Passing Percentage :
GRADUATION ;
(B. Sc. in Chemistry Honors) Gurukula Kangri Vishwavidyalaya, Hardwar, (Uttranchal) 1993 57.0
POST GRADUATION :
(M. Sc. in Analytical Chemistry) Gurukula Kangri Vishwavidyalaya, Hardwar, (Uttranchal) 1995 63.0
E-mail amitsharma_2439 AT yahoo.com, amitsharmaQA AT in.com, amitsharma2175 AT aol.com
Major Accountabilities :
** Corporate and Site Head for day to day operation and Head CQA for Policy decisions and implementation
** Track plant level Operational Excellence, KPI’s, KRA’s benefits and make plant MIS,
** Maintains an understanding of relevant production, in processes through online quality assurance systems.
** Initiate and Implement strategies to promote Operational Excellence in the plant /or at organizational level.
** Operational Excellence experience in Formulation production environment :
** Inventory Management.
** Throughput continuous improvement.
** Changeover time reduction.
** Yield Improvement.
** Ensure local quality systems at all locations are established and comply with Group/Corporate QA - company policy, standards, local statutory regulations and country regulations for those countries where product is marketed.
** Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, for products manufactured at the contract manufacturing sites.
** Ensure management training on and awareness of quality and compliance requirements and systems.
** Assess the conclusions of periodic review of process performance, product quality and of the Quality Management System.
** Ensure appropriate and timely escalation to management for quality related matters.
** Ensure all QA personnel are properly trained and qualified to execute their primary and secondary duties.
** Handling of market complaints, product recall , suspected counterfeit incidences, deviations & investigations etc.
** Quality audits of contract manufacturing sites, warehouses, API and packaging material vendors.
** Initiate product optimization projects.
** Support to the Drug Supplier Performance & Drug Regulatory Assurance activities.
** As a member of an site executive committee, participate in the management meetings.
** To conduct “Quality Committee” review meetings, develop and maintain effective business relationships with approved suppliers and receiving locations.
** Provide expert QA input to new product identities which includes assessing of new identified API & packaging vendors, establishing supply and supporting through to regulatory approval.
** Responsible for pre audit of Quality Assurance for Supplier Management including Annual Assessments; Quality Assurance technical agreements; trending and reporting of data in monthly compliance reports; assessing,
** Attending seminars related to plant and Lab. equipments, Quality and Business Review Meetings as and when required.
** Experience to deal with foreign consultants and inspectors.
** Successfully lead several regulatory inspections of USFDA, MHRA, MCC, TGA, ANVISA, EU etc.
** Establishing Quality Management Systems across various processes to reduce rejection levels and ensure high quality standards at all the stages of production
Key Competencies :
** Multi-site / multi-functional / International Standards QA implementation experience with respect to Corporate QA policies
** Proven experience in Quality Assurance or combination of Quality and Techno commercial activities.
** Postgraduate in Analytical Chemistry with wide experience in Quality Assurance cum Regulatory Affairs
** Knowledge of technology transfer from R&D to various B2B or own site and internationally in South Africa as well as Indonasia.
** Strong demonstrated knowledge of cGMPs, cGLP, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
** Excellent oral and written communication skills
** Always demonstrated my professional experience worked with cross-functionally and managing project initiation management skills.
** Strong problem solving and negotiating/influencing skills. Ability to initiate and implement work independently with team work, travel both in domestic and international assignments.
** Lead and build Empowered QA Teams and provide them continuous support in achieving quality output.
Professional Experience :
1) Theon Pharmaceuticals Limited,Period Employed from Aug. ‘11 to till date.
Designation/Grade Head Of Department (Corporate/Site Quality Assurance/Quality Control, ANDA’s, F&D, Stability, Third party Audit, New Vendor and Product Developments)- M4
Area of Operation Baddi (HP)/Panchkula (HR)
Nature of business Global player in the field of Manufacturing of Non sterile Tablet, Capsule, Dry Syrup, Sterile Injectable (DryPowder) with a turn over of 20 crore per month through Third Party Contract Manufacturing/B2B having largest no. of DGCI Molecules in Pharmaceutical formulations.
Job responsibilities :
1) Heading Corporate as well as Plant Quality Assurance/Quality Control, Stability section, F&Ds of own products and regulated market form indirect export.
2) Leading and Liasoning with statutory bodies like WHO, WHO-GMP, Weight & measures, ISO (9000) certifying bodies.
3) Leading and Monitoring independently Packaging Quality Lab for Primary, Secondary & Tertiary packaging materials, development in accordance with customer contract manufacturing requirement.
4) Leading a Team of 40-45 QA/QC Executives/Officers, 02 Plant QA/QC Asst. Gen. Managers, 06 F&D along with a team of 12-14 Associates for GxP, cGMP, Validation compliance, APQR.
5) Implementation of on-line inspection system, procedures and maintaining all stipulated optimum systems as per customer requirement
6) Conducting of internal quality audits in the organization to fulfill contract manufacturing requirement.
7) Conducting of external audits at the vendor site, vendor rating and their approvals for cost reduction projects.
8) Implementation of calibration procedures, SOP’s, working instructions of all Operational machines as well as QA/QC Lab.
Equipments as per regulated market guidelines.
9) Conducting training classes at all levels, Conducting online on job as well as classroom trainings for cGMP, cGLP, cGDP to support all related staff and managers.
10) Review & approval of Batch production record, monitoring yield reconciliation, Master protocol and summary reports including compatibility study..
11) Implementation of Cross functional investigations.
12) Complaint handling and their redressal, product stability studies and product recall system.
13) Implementation of validation and stability studies, also execute Validation Master plan & checking their execution.
14) Implementation of Change/Deviation control procedure by listing out deviations and to implement proper corrective action.
15) Review and authorization of Raw & Packaging material specifications, test procedure and operational procedures including Master formula, Technology Transfer , New drug molecules from R&D.
16) Implementation of market feed back system regarding product quality and stability.
17) Implementation of regularity approvals in Personnel Hygiene System, ISO 9001 (QMS), ISO 14000 (EMS), and WHO-GMP under Schedule M, H, T (in accordance with Drug & Cosmetics Act).
18) Implementation of product release system as per cGLP, cGMP, cGDP.
19) New Research and development activities Technology transfer, Scale Up Batch, Validation & Commercial related to ADL.
20) Commissioning, Validation & verification qualification as per IQ, OQ, DQ, PQ of all Laboratory equipments and plant machineries.
21) Process & product Validation of Injectables, Tablet, capsules & Liquid syrups.
22) Preparation of Site Master File, Master Batch Records, Updation of BMR, BPR, MBR and GMP files.
23) Review, Release & Approval of Art works of Unit cartons, Labels, Stiffeners, Wrapper, Shipper, Aluminum Foils, Glass vials, Ampoules, HDPE bottle & caps etc.
24) Co-ordination with R&D for Validation, Exhibit batches of our own new product.
25) To set up the In process Quality checks at every level of Process and Audit system.
26) Build up Quality team and consciousness among the business process and each individuals mind.
27) Leading Total Quality Assurance and establishment of Quality control tools.
28) Coordinate for the all Quality activities of QA at HO like planning, IPQA, packaging, Handling of Market complaints, Product Recalls, and their change control to avoid future occurrence.
29) Establishment of Quality Assurance facility and procurement of regulated inspection for new facility, Validations –Analytical Method validation, Analytical method transfers activity. Equipment and instrument validation protocol approval and certification, Review and approval of protocol and summary reports of compatibility study.
30) Research, Development and Implementation though Training, Wholly responsible for Designing & Implementing / ensuring Compliance to Quality ,Validation System & Analytical Assurance as per WHO-GMP & all International Guidelines.
31) Attending Regulatory and customer audits, Technical agreements review, Review of ANDA filing.(Previous)
2. Alkem Laboratories Limited :
Period : Employed from July'09 to Aug.’11.
Designation/Grade : Sr. Manager (Quality Assurance/Quality Control, ANDA’s, Stability, Technology Transfer-M8
Area of Operation : Gangtok (Sikkim) / Baddi / Daman / Taloja (Mumbai)
Nature of business : Global player in the field of Manufacturing of Non sterile Tablet, Capsule, Sterile Injectables (Dry Powder)
with a turn over of 2500 cr. through own leading brand. No.7 ranking in Pharmaceutical formulations.
3. Ranbaxy Laboratories Limited, (100% Export oriented unit) :
Period : Employed from June '02 to June ‘09.
Designation : Sr. Manager (Quality Assurance)-M03
Nature of business Multicrore formulation MNC set on a high growth path specializing in Non sterile Formulation tablet,
Soft & hard gelatin capsules with Modern & sophisticated 100% Export plant, Regulated by US-FDA,
UK-MHRA, SA-MCC, Aust. - TGA, JAPAN, Brazil-ANVISA, Uganda – NDA, Canada – TPP,
Europe-EMEA, EU-GMP and WHO- GMP (Geneva) regulatory and non regulated markets.
Area of Operation : Poanta Sahib, (Himachal Pradesh)/Dewas (MP)
4. SABOO-BERLAC Limited (a joint venture & technical collaboration with Berlac AG, Switzerland) :
Period : Worked from July '00 to June '02
Designation : Sr. Executive (QA, QC, Production, ISO certifications).
Nature of Business : Designer finishes, Specialty Paints, Lacquers, Thinners for industrial purpose.
Area of Operation : Industrial Area, Chandigarh (Punjab)
5. ICI PAINTS Limited (Indian collaboration with Imperial Chemical Industries, London) :
Period : Worked from Dec.'97 to June'00
Designation : Production Associate (Chemical & Product development).
Nature of Business : Automotive, Refinish, Decorative, Motor & Industrial paints and Thinners
Area of Operation : Industrial Area, Mohali (Punjab)
6. HONEY-BEE NATURAL PRODUCTS Limited (100% Export oriented unit of Dabur Group) :
Period : Worked from Oct.'95 to Oct.'97
Designation : Production cum Approved Agmark Chemist.
Nature of Business : Export of Bulk Honey processing, honey based Food and ayurvedic products.
Area of Operation : Lalru, Distt: Patiala (Punjab)
Place :
Date ;