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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi
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Amneal Pharma - Walk in - 15th Mar'20 at Panchkula AMNEAL PHARMACEUTICALS PRIVATE LIMITED

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Amneal India walk in interview 2020

Amneal Walk in Job Requirements

  • 2 - 7 Years of experience
  • 100 Vacancies available 
  • Ahmedabad(Moraiya)
Dosage form-
parenteral, usfda, Vial, documentation, sterile, quality procedures, Ophthalmic, production department, pharma

Job Responsibilities Required

Company looking for competent, dynamic and varstile candidates for Injectable unit for Ahmedabad SEZ Matoda Plant.

Date: 15th Mar, 2020 (Sunday)
Timing: 9:00 AM to 4:00 PM

Venue :
WHRamgarhHeritage , Panchkula,
Address: The Quila, NH-73, near Sector 28,Ramgarh, Haryana 134111

INJECTABLE REQUIREMENT

Sterile Manufacturing ( Injectable unit /Parenteral Unit)

Designation: Executive/ Sr. Officer/ Officer/ Operators
Qualification: M. Pharm/ B.Pharm/ Diploma Engineering/ D. Pharm/ B.Sc/ ITI
Total Experience: 02 to 07 years
Area: Ophthalmic, Vial, PFS, LYO
Required Job specifications: Aseptic area, Controlled area, Sealing, Filling, capping, Production QMS
Position: Officer: 30
Operator: 75 
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Desired Profile:
  • To observe & follow all rules and regulations of the production department.
  • Must be from Parenteral background
  • To be aware and responsible for achieving quality objective and fulfilling the requirements of the quality of the company's service by means of applicable quality procedures.
  • Sound technical knowledge of Aseptic area and controlled are related activities.
  • Technical exposure and expertise on vial filling, sealing, Autoclave, Lyophilizer, PFS filling, cartridge filling machine.
  • Knowledge of Regulatory guidelines and exposure of USFDA audits.
  • Knowledge of Eye drop filling machine and related batch mfg. process.
  • Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable.
  • Expertise in batch manufacturing and preparation related activities.
  • Knowledge of equipment validation and qualifications in injectable.
Required Candidate profile:
The candidate with good communication and inter personal skills, computer knowledge and exposure to cGMP/ GLP Knowledge and understanding of regulatory requirement is essential.

 Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organisation. You may walk in for interview with updated CV along with CTC proof, Appointment letter, Increment letter & last 3 months salary slip & Bank statement, Aadhar & PAN card and 2 passport size photograph.

If you are unable to attend interview you can share cv onneha.modi@amnealindia.com orkishan.soni@amnealindia.com

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