Aurobindo Pharma Ltd. is looking for candidates for the post of Executive / Senior Executive in Assessment and Qualifications Alliance (AQA) for Formulation department (OSD – Oral Solid Dosage). Please refer the details given here to apply.
AUROBINDO PHARMA LTD’ (APL). APL is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. APL is 2nd Largest Generic Company as per Rx dispensed in the USA. APL is among the Top 10 Generic player in France, Germany, Portugal, UK, Italy, Czech Republic, Netherlands & Belgium. APL manufactured 33 Billion+ diverse dosage forms in 2018-19. APL has 27 manufacturing facilities and 5 R&D centres worldwide.
Title: Executive / Senior Executive (AQA)
Department: Formulations (OSD)
Qualification: B.Pharm/ M.Pharm/ M.Sc
Experience: 3 to 10 years
Location: Naidupeta, Andhra Pradesh
Salary: Not Disclosed
Skills: AQA, OOS, Empower software, OOT, Documentation, Implementation of CAPA, Incidents, Annual trends, Regulatory Compliance, Audit Trails
Roles and Responsibilities (AQA):
- Review of all analytical data generated in the laboratory.
- Review calibrations of all analytical instruments.
- Ensuring the laboratory in always ready to audit condition.
- Actively participating in internal/CQA and regulatory audits.
- Review of investigation report ,protocol, reports.
- Preparing fortnightly, monthly, quarterly, annual trends.
- Review of analytical investigations (such as OOS, OOT, incidents), Root cause analysis of Quality related issues and Implementation of CAPA
- Review of Electronic raw data, audit trails in Empower software (HPLC, UPLC), Standalone Instruments such as UV, FTIR, AUTOTITRATOR, Malvern master sizer, LBPC,TGA, DSC, IC etc.
- Documentation Control: ensuring archival / retrieval and updating of documentation as
per regulatory compliance
- Attending regulatory queries and providing necessary information to Regulatory affairs.
- Verification of Qualification Documents from Quality Control.
- Responsible for all activities in the Quality Assurance, including cGMP/cGLP/cGXP, documentation and implementation of departmental quality systems.
Desired Candidate Profile
- Ideal candidate should be a B.Pharm or M.Pharm or M.Sc with 3 to 10 years of experience from FDA regulated plant.
- Preference will be given only to candidates who are Formulations – OSD background.
Perks and Benefits
- Salary will be best and based on candidate caliber and competency.