Opening for Head- QA/QC in Shree Dhanvantary Pharmaceutical Analysis & Research centre
Shree Dhanvantary Pharmaceutical Analysis and Research Centre (SDPARC) is a contract research organization established in 2006 and is managed by RIBOSOME PHARMA PVT. LTD., Surat. SDPARC offers a wide range of analytical & research services for small, medium and large scale pharmaceutical, ayurvedic, bulk drug, chemical, food and cosmetic industries.
The centre is approved by the Food and Drug Control Administration (FDCA), Gujarat state as a public testing laboratory and is spread over 8,000 sq. ft. area.
The center is equipped with state of the art analytical facilities to cater to the needs of our clients and provides accurate, prompt and cost-effective analytical services in compliance with cGMP, GMP and various pharmacopeia guidelines.
Post: Head- QA/QC
1. Provide technical direction for the development of Pharmaceutical drug testing laboratory / Public testing laboratory as per NABL.
2. To manage the laboratory as per Schedule L1, NABL ISO/IEC 17025.
3. Identify the relevant NABL /QA / GLP / GMP/ ISO training needs and opportunities.
4. Ensuring stringent adherence to quality standards, norms & practices, identifying gaps and taking corrective action.
5. To ensure that awareness of cGMP, ISO, ICH requirements are evaluated and updated through training and audits.
6. Handling and replying to customer queries / complains / Regulatory curie.
7. Day to day management of laboratory activities.
8. Managing sponsor audits.
9. Other duties as assigned.
1. Good knowledge of Quality Management System (QMS), Quality Assurance (QA), Quality Control (QC), NABL / GLP / GDP / cGMP / Schedule L1 etc.
2. Hands-on experience with instruments like GC, AAS, HPLC, FTIR, KF, Dissolution, UV spectrophotometer, IR spectroscopy, conductivity meter, Flame Photometer, CO
3. Analyzer, ion Selectivity meter, TOC etc.
4. Analytical method development & validation for ANDA market.
5. Knowledge about software Quality control management system, LIMS, Chromeleon & other related softwares.
5. Proven ability to exercise good judgment and effectively balance work and changing priorities.
6. Good writing and communication skills.
7. Ability to finish the assigned task within pre-determined time line..
Experience: Minimum 6 years of relevant experience in R&D / CRO / QC / Manufacturing / Drug testing
Qualification: M.Pharm, M.Sc, Ph.D
Location: Surat - Gujarat
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA/QC
End Date: 30th September, 2018
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