Resume - Postgrdaute in Analytical Chemistry with 13.5 yrs exp in Quality Assurance (Phar...

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Resume #83349

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Date of Birth 11th March 1972

Caste/Religion Hindu/Brahmin

EQualification Board/ University Year of Passing Percentage
10th (Science Stream) U.P. Board, Allahabad 1987 52.0
10+2 (Maths Stream) U.P. Board, Allahabad 1990 50.0
GRADUATION
(B.Sc.)(Chemistry Hons) Gurukula Kangri Vishwavidyala, Hardwar, (Uttranchal) 1993 57.0
POST GRADUATION
(M.Sc. in Analytical Chemistry) Gurukula Kangri Vishwavidyala, Hardwar, (Uttranchal) 1995 63.0

Professional Experience:

1. Health Biotech Limited,
Period Employed from Sept. '08 till date.
Designation Deputy General Manager (Quality Assurance/Improvement)
Area of Operation Baddi (Himachal Pradesh)
Nature of business Global player in the field of Contract Mfg. of Sterile Injectables
(Dry & Liquid), Liquid syrup, Anticancer & Personal care products with a turn over of 120 crore through own leading brand and
B2B Business of MNC like Cipla, Nicholas, Sherya, Claris, German
Remedies, Panacea Biotech, Piramal, Cadila etc.
Job responsibilities:
1)Presently working on technology transfer for B2B & contract manufacturing of various products of MNC Customers.
2)Leading and Liasoning with statutory bodies like WHO, FDA, Weight & measures, ISO certifying bodies.
3)Leading and Monitoring independently Packaging Lab for Primary & Secondary packaging materials and their development in accordance with customer requirement.
4)Implementation of on-line inspection system, procedures and maintaining all stipulated systems.
5)Conducting of internal quality audits in the organization to fulfill contract manufacturing requirement.
6)Conducting of external audits at the vendor site, vendor rating and their approvals for cost reduction projects.
7)Implementation of calibration procedures, SOP's, working instructions of all Operational machines as well as QA/QC. Lab. Equipments as per regulated market guidelines.
8)Leading a team of 20 Executives and officers in IPQA/QC department.
9)Conducting training classes at all levels.
10)Issuing and monitoring Batch production record and monitoring yield reconciliation.
11)Implementation of Cleaning system and Cross contamination controls.
12)Implementation of Cross functional investigations.
13)Complaint handling and their redressal, product stability studies and product recall system.
14)Implementation of validation and stability studies, also execute Validation Master plan & checking their execution.
15)Implementation of Change/Deviation control procedure by listing out deviations and to implement proper corrective action.
16)Preparation of Raw & Packaging material specifications, test procedure and operational procedures including Master formula.
17)Implementation of market feed back system regarding product quality and stability.
18)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).
19)Implementation of product release system, Implementation as per cGLP, cGMP.
20)New Research and development activities related to PDL.
21)Commissioning, Validation & verification qualification as per IQ, OQ of all Laboratory equipments & plant machineries.
22)Process & product Validation of Injectables, Tablet, capsules & liquid syrups.
23)Preparation of Site Master File, Master Batch Records, Updation of BMR, BPR, MBR and GMP files.
24)Release of Batch Designing & Approval of Art works of Unit cartons, Labels, Stiffners, Wrapper, Shipper, Aluminum Foils, HDPE bottle & caps etc.
25)Co-ordination with R&D for Validation, Exhibit batches of our own new product.
26)To set up the In process Quality checks at every level of Process and Audit system.
27)Build up Quality team and consciousness among the business process and each individuals mind.
28)Leading Total Quality Assurance and establishment of Quality control tools.
29)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.
30)Establishment of Quality Assurance facility and procurement of inspection for new infrastructure.

(Previous)
2. Ranbaxy Laboratories Limited,
Period Employed from June '02 to August '08.
Designation Sr. Manager (Quality Assurance)
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 regulatory and non regulated markets.
Area of Operation Paonta Sahib, (Himachal Pradesh)

3. 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)

4. 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)

5. 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)

Salary Drawing CTC 8.00 Lac. PA (Next revision of salary in April 2010)
Employment Preferences
Expected Monthly Salary: 20 – 30 % growth in present CTC or as per your company policy/grade
Availability: One month advance notice or Basic salary after receiving offer letter.
References
TO BE PROVIDED AT THE TIME OF FINAL INTERV IEW ON REQUEST ONLY.

Date: 01 / 06 / 2009

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