Manager/ Sr. Manager - GMP

Jubilant Life Sciences
  • Roorkee
  • Confidential
  • 8-15 years
  • 03 Jul 2015

  • Quality Control - Product/ Process, Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Summary of Job (Purpose/ objective of the job)

The position will be responsible for activities related to conducting cGMP training at site in all the functions like QA, QC, Microbiology, Warehouse, Manufacturing, HR & Engineering.

To provide training to all new employees on Basic GMP through induction
Preparation/ Planning/ Execution of Annual Training
Measuring effectiveness of cGMP training on the Shop Floor by periodic auditing, asking questions on various SOPs and quizzing
To identify the external training required for the plant personnel and nominate for the participation
Provide training on Shop Floor on Systems Vs Practices Vs Gaps observed
Shall be responsible for compliance of cGMP Annual Training Calendar.
Keeping track with current regulatory trends from the regulatory sites, GMP trends and update quality systems accordingly
Shall be responsible for conducting unplanned audits in various functions like QC, Engineering, Production & Warehouse in Jubilant
Preparation/Planning/Execution of Monthly GMP Calendar
Streamlining training process by conducting GAP Analysis and rectifying the gaps.
To attend internal/external training as a part of learning.
To derive trainings for the various functions from the Audit observations/IPQA Observations/ Market complaints.
To check the implementation/awareness of CAPA by providing training on the CAPA proposed to various functions.
To execute vendor qualification activity as per regulatory requirements
Preparations and updating Audit schedule, Re-Qualification calendar for Raw materials, Packaging materials and maintain vendor documents.
Creation, delation and updating vendor information in BaaN.
Review of R&D, plant specifications during new item code creation.
Filling of customer questionnaires and providing required documents to customers.

Desired Profile Qualification & Experience

Experience: 8-15 years

BSc/MSc (Organic Chemistry) or B Pharm/M Pharm

Key Competencies ( Technical, Functional & Behavioral)

Good communication skills-verbal & written
Good presentation skills.
A self-starter and highly responsible individual with strong analytical abilities.
Experience in processes related to solid Dosage form manufacturing.

Job Posted By

About Organisation

Jubilant Life Sciences