Careers

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Job Title : Sr. Officer - Validation

Department: Validation
Office: Thane, India
Project Location: Anywhere within & Outside India

Job Description :
  1. Academics/Qualification
    HSC + Min. 3 years Diploma in Pharma, science, biological or pharmaceutical manufacturing + Min 7 years experience of working in Pharmaceutical industry for Validation department.
    or
    Min. Four years Bachelor's degree in Pharma, science, biological or pharmaceutical manufacturing + Min 4 years experience of working in Pharmaceutical industry for Validation department
  2. Responsibilities
    1. Comprehend and implement SPECTRUM standards & Guidelines while delivery any job task
    2. Prepare / Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    3. Prepare Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    4. Prepare / Review Commissioning Protocols/checklist for Utilities
    5. Standardization of validation documents
    6. Supervise / witness qualification process at site
    7. Compile Final Validation documentation package
    8. Perform and support QA functions of Department
    9. Plan subtask for self and subordinates and remain accountable for self and subordinate manhour expenses
  3. Experience / Knowledge / Technical Skills Required
    1. Experience of preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation facility
    2. Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and Biotech formulation facility from qualification point of view
      • Process equipment
      • HVAC system
      • Clean utility systems
    3. Read and understand isometric, P&ID and as built drawings

Job Title : Executive - Validation

Department: Validation
Office: Thane, India
Project Location: Anywhere within & Outside India

Job Description :
  1. Academics / Qualification
    HSC + Min. 3 years Diploma in Pharma, science, biological or pharmaceutical manufacturing + Min 9 years experience of working in Pharmaceutical industry for Validation department
    or
    Min. Four years Bachelor's degree in Pharma, science, biological or pharmaceutical manufacturing + Min 6 years experience of working in Pharmaceutical industry for Validation department
  2. Responsibilities
    1. Comprehend and implement SPECTRUM standards & Guidelines while delivery any job task
    2. Prepare / Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    3. Prepare / Review Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    4. Prepare / Review Commissioning Protocols / checklist for Utilities
    5. Standardization of validation documents
    6. Supervise / witness qualification process at site
    7. Compile Final Validation documentation package
    8. Conduct FAT
    9. Perform and support QA functions of Department
    10. Plan subtask for self and subordinates and remain accountable for self and subordinate manhour expenses
    11. Correspondence with clients and all project stake holders effectively & impressively
    12. Lead / represent Project Meeting with client
    13. Independently Clarify Client queries/comments technically in line with the regulatory guidelines and to the satisfaction of Client in project meetings vide PP presentations
    14. Prepare Project schedules
    15. Prepare and submit monthly Reports
  3. Experience / Knowledge / Technical Skills Required
    1. Knowledge and understanding of all relevant international / local Guidelines related to Qualification & Validation for Pharma Facility
    2. Experience of leading a team of min. 4 subordinates
    3. Experience of preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation facility
    4. Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and Biotech formulation facility from qualification point of view
      • Process equipment
      • HVAC system
      • Clean utility systems
    5. Read and understand isometric, P&ID and as built drawings
    6. Experience of co-ordinating and interacting with International regulatory body (USFDA, EU, PICS) during plant Audits

Job Title : Manager - Validation

Department: Validation
Office: Thane, India
Project Location: Anywhere within & Outside India

Job Description :
  1. Academics / Qualification
    Min. Four years bachelor's degree in Pharma, science, biological or pharmaceutical manufacturing + Min 10 years experience of working in Pharmaceutical industry for Validation department
  2. Responsibilities
    1. Comprehend and implement SPECTRUM standards & Guidelines while delivery any job task
    2. Prepare / Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    3. Prepare / Review / Approve Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    4. Prepare / Review / Approve Commissioning Protocols / checklist for Utilities
    5. Standardization of validation documents
    6. Supervise / witness qualification process at site
    7. Review and approve Qualification / validation reports
    8. Prepare / approve SOP’s for cleaning & process validation etc.
    9. Compile Final Validation documentation package
    10. Conduct FAT
    11. Perform and support QA functions of Department
    12. Plan subtask for self and subordinates and remain accountable for self and subordinate manhour expenses
    13. Correspondence with clients and all project stake holders effectively & impressively
    14. Lead / represent Project Meeting with client
    15. Independently Clarify Client queries&comments technically in line with the regulatory guidelines and to the satisfaction of Client in project meetings vide PP presentations
    16. Prepare Project schedules for entire process of Q&V
    17. Keep abreast with latest Guideline updates
    18. Prepare and submit monthly Reports
    19. Activity & resource Planning
    20. Billing as per projections
    21. Cash flow as per projections
    22. Set PBIS/KRA for team
    23. Identify training need for the team members and develop them for Validation scope services
    24. Keep the team motivated and remain responsible for team performance
    25. Support in Marketing Functions for technical details as required
    26. Conduct inspection of existing facilities and prepare GAP analysis report
  3. Experience / Knowledge / Technical Skills Required
    1. Knowledge and understanding of all relevant international / local Guidelines related to Qualification & Validation for Pharma Facility
    2. Experience of leading a team of min. 8 subordinates
    3. Experience of preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation facility
    4. Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and Biotech formulation facility from qualification point of view
      • Process equipment
      • HVAC system
      • Clean utility systems
    5. Read and understand isometric, P&ID and as built drawings
    6. Experience of co-ordinating and interacting with International regulatory body (USFDA, EU, PICS) during plant Audits

Job Title : Sr. Manager - Validation

Department: Validation
Office: Thane, India
Project Location: Anywhere within & Outside India

Job Description :
  1. Academics / Qualification
    Min. Four years Bachelor's degree in Pharma, science, biological or pharmaceutical manufacturing + Min 12 years experience of working in Pharmaceutical industry for Validation department
  2. Responsibilities
    1. Comprehend and implement SPECTRUM standards & Guidelines while delivery any job task
    2. Prepare / Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    3. Prepare / Review / Approve Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement for following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility
      • Process equipment
      • HVAC system
      • Clean utility systems
    4. Prepare / Review / Approve Commissioning Protocols / checklist for Utilities
    5. Standardization of validation documents
    6. Supervise / witness qualification process at site
    7. Review and approve Qualification/validation reports
    8. Prepare / approve SOP’s for cleaning & process validation etc.
    9. Compile Final Validation documentation package
    10. Conduct FAT
    11. Perform and support QA functions of Department
    12. Plan subtask for self and subordinates and remain accountable for self and subordinate manhour expenses
    13. Correspondence with clients and all project stake holders effectively & impressively
    14. Lead / represent Project Meeting with client
    15. Independently Clarify Client queries / comments technically in line with the regulatory guidelines and to the satisfaction of Client in project meetings vide PP presentations
    16. Prepare Project schedules for entire process of Q&V
    17. Keep abreast with latest Guideline updates
    18. Prepare and submit monthly Reports
    19. Activity & resource Planning
    20. Activity & resource Planning
    21. Billing as per projections
    22. Cash flow as per projections
    23. Set PBIS / KRA for team
    24. Identify training need for the team members and develop them for Validation scope services
    25. Keep the team motivated and remain responsible for team performance
    26. Support in Marketing Functions for technical details as required
    27. Conduct inspection of existing facilities and prepare GAP analysis report
  3. Experience / Knowledge / Technical Skills Required
    1. Knowledge and understanding of all relevant international/local Guidelines related to Qualification & Validation for Pharma Facility
    2. Experience of leading a team of min. 8 subordinates
    3. Experience of preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation facility
    4. Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and Biotech formulation facility from qualification point of view
      • Process equipment
      • HVAC system
      • Clean utility systems
    5. Read and understand isometric, P&ID and as built drawings
    6. Experience of co-ordinating and interacting with International regulatory body (USFDA, EU, PICS) during plant Audits

Job Title : Designer - Piping

Job Description :
  1. Academics/Qualification
    Diploma in Mechanical Certified in Revit & Plant 3D and post Graduate Diploma in piping will be an added advantage
  2. Skills Required
    1. Should have thorough knowledge in piping (Revit)
    2. Should have knowledge to create a family on revit
    3. Able to extract BOQ, isometric drawings, equipment lay out
    4. Required to handle fire, ETP, piping layout
  3. Experience
    1. 6 - 8 years

Job Title : Officer - Projects (Total 4 Nos)

Qualification : B.E. Chemical / Mechanical
Experience : 2 to 3 yrs / in Pharma formulation facility design

Job Description :
  • Conceptualization of projects and design development
  • Project planning, Multi Disciplinary co-ordination, vendor management, good communication skills
  • Project Tracking & Reporting , Document management
  • Site visits & Site co-ordination
  • In house co-ordination with the Engg. Team
  • Good in AutoCAD & exposure to revit

Job Title : Draughtsman Electrical (Total 2 Nos)

Qualification : 12th pass & Diploma / B.E. in Electrical
Experience : 3 yrs

Job Description :
  • Making electrical layouts, using revit tools, Schematic, SLDs, MEP Coordination

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