Position: Officer - Quality Assurance (QA) - Pharmaceuticals

• 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.

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

Pharma / Biotech / Clinical Research

Production, Manufacturing, Maintenance

Production/Manufacturing/Maintenance

Quality Assurance/Quality Control Executive

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

(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

Kalpana

044-27975056

QA-1