Hyderabad

Title QA Manager
Services Quality Assurance
Job Function Quality Assurance
Job Grade Managerial – M1
SBU/ Division Inogent – API
Candidate Profile Qualification M.Sc./M.Pharm.-Chemistry (Organic/Analytical)
Experience 7 – 10 years
Job Responsibilities
    Ensure that Quality Assurance guidelines are adhered to by:

  • Ensure that detailed written procedures are available for processes that could affect the quality of the finished product and those are adhered to
  • Ensure adherence to GMP/GLP/GDP guidelines across the organisation
  • Releasing or rejecting API’s / Intermediates
  • Review and submission of USDMF / CTD / COS.
  • Review and submission of technical packages for various regions.
  • Prepare the site for customer/ Regulatoy audits and ensure prompt response and compliance.
  • Ensure SOPs are available for all quality related activities and are current.
  • Approving Procedures like SOPs, Specs, MOAs, BMRs Master formulae, forms etc.
  • Ensure all deviations are addressed before release of all products.
  • Ensure changes are handled with proper justification.
  • Handling of the customer complaints.
  • Ensure maintenance and calibration of equipment/instrument as per schedule.
  • Preparation and Review of Annual Review Reports.
  • Response to queries from regulatory /Customer.
  • Review of site master file and ensure that is available in plant with complete details.
  • Conducting management review meeting.
  • Ensure vendor qualification.
  • Handling of New product developments.
  • Ensuring the fulfillment of training activities as per SOP.
  • Zero deviation from SOPs/ norms/ regulatory requirements & escalate deviations (if any). Recommend corrections.
    Handling of Audits :

  • Ensure internal audits are carried out as per schedule and necessary corrective active preventive action is taken.
  • Host regulatory audits and provide response to queries
    Ensure Good Documentation Practices (GDPs) :

  • Accurate & up-to-date technical documents in accordance with regulatory compliance.
  • Archival & retrieval of documents
  • Prepare / review documents /reports as maybe required
    Maintain records, data integrity & safety :

  • Maintain strict data integrity and adhere to all related policies
  • Understand & adhere to safety norms
    Ensure skill development of self & team:

  • Guide team to meet productivity & quality targets.
  • Train & develop team members through knowledge sharing sessions and nominate for training programs
  • Improve knowledge of production techniques / processes, etc. through one on one discussions with supervisor/ regular classroom trainings/ project trainings/further educational programs etc.
  • Focus on developing behavioral competencies through behavioral training workshops and feedback discussion with manager