Manager / Sr. Manager – Quality Assurance – Tarapur (boisar)

10 - 15 Years
Mumbai

Job Description

Dear Candidate,

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)

Reporting & Responsibility: Plant head & Director in USA.


Experience:

  • 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.

Key responsibilities: 

 
  • 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.

Functional Competencies:


  • 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.

Behavioral Competencies:


  • Customer Focus
  • Timely Decision Making
  • Delivering Consistent Results
  • Listening
  • Cross Culture Skills
  • Team and People Development
  • Strategic Thinking
Company Accomodation:

  1. 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. 
  2. Suburban local trains from Churchgate now connect Boisar Railway station.
  3. For bachelors, Company has guesthouse with a cook.
  4. Company provides accommodation if needed for outstation candidates. 
Those who qualify the above requirement, kindly share their updated CV to: pharmaplacement2@gmail.com

Contact Number

Office : 9820360083

Mr. Sudhir Vinayak (DIRECTOR) : 9820234987

Salary: INR 15,00,000 - 17,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Manager

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Sc - Any Specialization, B.Pharma - Pharmacy

PG:MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy

Doctorate:Doctorate Not Required

Company Profile

Pharma Placements Inc.

We provide quality man power services to Pharmaceutical indusstry.
View Contact Details+

Recruiter Name:Pharmaplacement team

Contact Company:Pharma Placements Inc.

Telephone:9820360083

Address :G-55, Ground Floor, A Wing,, Express Zone Mall, Opp Reliance Power, W.E.Highway Goregaon (East)

Website:https://www.pharmaplacements.com/