One of our reputed Pharmaceutical client is looking for qualified Professional for the role of Manager / Sr. Manager - QA to be based at Tarapur.
About the Company -
The Company has been consistently growing faster than the Indian Pharma Market. They have Manufacturing of Hard Shelled Capsules, Hard Gelatin Capsules & Soft Gelatin Capsules. The company's 95% of sales are in USA, Europe, Japan and Australia and New Zealand Market and a world leader in their products.
The requirement is as follows -
Role : Manager / Sr. Manager - QA
Qualification :B. Sc / M. Sc / B. Pharma / M. Pharma
Job location : Tarapur MIDC, (Boisar)
- Experience of around 10+ years in Quality Assurance and exposure in Regulatory Affairs in Pharmaceuticals or Food or related industries.
- Experience in handling technical issues, customer complaint and replies to International customers.
- Knowledge of Indian Pharmacopoeia, US Pharmacopoeia and European Pharmacopoeia.
- Experience in ISO, SPC, cGMP
- Experience in 5S preferable.
- Coordinate and communicate with international customers and Sales team at USA for resolving technical issues and investigating and closing customer complaints.
- Establish and maintain compliance with Indian FDA (including registration, new product submissions) and other regulatory affairs
- To be the main point of contact for all regulatory communication for the Capsule division. (Incident reports, audits, registrations etc.)
- Handling internal and external audit, Auditing vendor quality systems.
- Training Programs related to Quality and GMP Review and up gradation of site documents as per the regulatory / customer requirements.
- Ensure manufacturing process and product complies with international standards & customer specifications.
- Establish and monitor standards, SOPs, systems and process validation.
- Review and monitoring of Process quality, Product quality, Deviation, Corrective action and preventive action, Packing material quality, Labeling, Batch Manufacturing Record / Batch Process Record Monitoring.
- Prepare sampling procedures and directions for recording and reporting quality data. Analyzing data, making conclusion from data and distributing statistical information.
- Writing technical report, monthly progress report.
- Excellent written & verbal English communication skill.
- Technically competent in understanding technical issues and resolving customer complaints.
- SPC, data analysis and making conclusions
- Experienced with quality improvement concepts.
- Customer Focus
- Timely Decision Making
- Delivering Consistent Results
- Cross Culture Skills
- Team and People Development
- Strategic Thinking
- Tarapur- Rly station Boisar is 85 Kilometers from Mumbai and takes 1.5 hrs by train from Borivali Station or by road via Western Express Highway.
- Suburban local trains from Churchgate now connect Boisar Railway station.
- For bachelors, Company has guesthouse with a cook.
- Company provides accommodation if needed for outstation candidates.
Office : 9820360083
Mr. Sudhir Vinayak (DIRECTOR) : 9820234987
Salary: INR 15,00,000 - 17,00,000 P.A.
Role:Quality Assurance/Quality Control Manager
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Sc - Any Specialization, B.Pharma - Pharmacy
PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
Pharma Placements Inc.
Recruiter Name:Pharmaplacement team
Contact Company:Pharma Placements Inc.
Address :G-55, Ground Floor, A Wing,, Express Zone Mall, Opp Reliance Power, W.E.Highway Goregaon (East)