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Officer - Quality Assurance (QA) - Pharmaceuticals

By: Pharma Jobs | Views: 2158 | Date: 19-Aug-2013

ArudaaVis Labswww.arudaavis.comThe company is an Export Oriented Pharmaceutical Intermediates/API/bulk drug manufacturing unit with main focus on US and European Markets. The company is located about 30 KM North from Chennai, 5 KM from Ponneri

Position: Officer - Quality Assurance (QA) - Pharmaceuticals

by ArudaaVis Labs in Chennai
Experience: 3 to 5 yrs.  | Salary: INR 1,75,000 - 3,00,000 P.A  |  Opening(s): 1

ArudaaVis Labs

Job Description
  • Thorough knowledge and understanding of cGMP requirement by USFDA and Other Regulatory Agencies like WHO, EMA, TGA etc.
  • The incumbent will be responsible for the entire Quality function of the API Manufacturing plant situated in Chennai.
  • Responsible for documentation, validation, internal & external Audit, handling customer complaints & Regulatory affairs.
  • Minimum of 2-4 years Quality Assurance experience in the Pharmaceutical/ API/Bulk Drug Manufacturing Industry is must.
  • B.Pharm/M.Pharm/M.Sc Pharmacy or Chemistry graduate from a reputed University.
  • Must be willing to work at the Chennai outskirts.
  • Good understanding of Drug Development Process, cGMP, GLP Compliance and familiarity with USP, EP, IP etc.
  • Responsible for the preparation of Master Validation Plan, Quality Manual and Implementation of Quality System.
  • Issuance of documents for Production, QC and Packing related activities.
  • Review and approval of Batch Process Records (BPRs), Master Production Record (MPR's) and Standard Operating Procedures (SOP's) etc.
  • Issuance and review of Certificate of analysis (CofA) and Release of drug products. 
  • Support and Review of Validation protocols and Reports.
  • Support QC department in method development, method validation, stability testing.
  • Responsible for Vendor Evaluation, Qualification and Audit.
  • Organize and Conduct Periodic cGMP Training to Employees of all Departments.
  • Responsible for Change control management, deviations management, OOS investigation.
  • Support Regulatory submissions to various Health Authorities including US, EU and Row.
  • Preparation and submission of annual product review to regulatory agencies.
  • Coordination with all departments regarding documentation requirements.
  • Candidate should have Effective Communication Skills.
  • Enthusiastic, Energetic, Honest and Hard Working.
Salary:

INR 1,75,000 - 3,00,000 P.A

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Production, Manufacturing, Maintenance

Role Category:

Production/Manufacturing/Maintenance

Role:

Quality Assurance/Quality Control Executive

Keyskills:

Quality Assurance, Quality, Qualifty Officer, FDA, Regulatory Writing, Regulatory Reporting, Regulatory, Documentation, Document control, Review, Validation, Customer Complaint, Audit, Qualification

Desired Candidate Profile

Education:

(UG - B.Pharma - Pharmacy, B.Sc - Chemistry) AND (PG - M.Sc - Chemistry, M.Pharma - Pharmacy) AND ( Doctorate - Doctorate Not Required)

  • The candidate should be a Pharmacy/Chemistry graduate 
  • Candidate should have minimum 3-5 years experience in a pharmaceutical / chemical/bulk drugs Process Industry 
  • Should have Sound Knowledgeable in Principles of cGMP and Quality Aspects
  • Candidate should possess leadership qualities 
  • Candidate should have thorough exposure to USFDA and other regulatory agencies requirement. 
  • Candidate should be capable of handling internal and external audit. 
  • Candidate should be an Enthusiastic and Energetic Person
  • Should have excellent communication skills
  • Should be Honest and Hard Working.
  • Highly motivated individuals with Quality Assurance experience in the API/Pharma/bulk drug industry are encouraged to send their resume in word/pdf format mentioning your present employer, location, CTC and experience.

Company Profile

ArudaaVis Labs
http://www.arudaavis.com
The company is an Export Oriented Pharmaceutical Intermediates/API/bulk drug manufacturing unit with main focus on US and European Markets. The company is located about 30 KM North from Chennai, 5 KM from Ponneri

Contact Details
Recruiter Name:

Kalpana

Telephone:

044-27975056

Reference Id:

QA-1

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