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6 Polmon Instruments Jobs

Assistant Manager - Process & Documentation ( Automation)

6-8 years

Hyderabad / Secunderabad

1 vacancy

Assistant Manager - Process & Documentation ( Automation)

Polmon Instruments

posted 26d ago

Job Role Insights

Fixed timing

Key skills for the job

Job Description

Role & responsibilities


  • Understanding the user requirement.
  • Technical detailing
  • Getting pending data from customer.
  • Coordinating with respective teams and scheduling CRM
  • Sharing IPD's and getting filled IPD's from Customer.
  • Getting PFDs/P&ID's approval from Customer.
  • URS from customer
  • List of Validation Documents approval
  • Preparation of KOM presentation
  • Scheduling KOM and sharing Agenda to Customer.
  • Clarifying the points raised during CRM with customer
  • Conducting KOM as per the agenda and recording the MOM of KOM
  • FRS Preparation

In addition to above Job Responsibilities: (but not limited to)


1. Validation Strategy and Planning

  • Develop and implement a comprehensive validation strategy and validation master plan (VMP) in line with regulatory guidelines (FDA, EU GMP, WHO).
  • Establish timelines, objectives, and priorities for validation activities to support the project schedule and compliance requirements.
  • Work with cross-functional teams to ensure validation requirements are considered in project planning phases.

2. Leadership and Team Management

  • Supervise and mentor the validation team, assigning responsibilities and overseeing daily activities to ensure timely and effective validation work.
  • Conduct training sessions for validation personnel on current Good Manufacturing Practices (cGMP), validation protocols, and industry standards.
  • Assess team performance, provide feedback, and identify skill gaps to facilitate continuous improvement.

3. Documentation and Compliance Management

  • Ensure that all validation documentation, including protocols, reports, and supporting documents, is complete, accurate, and compliant with Good Documentation Practices (GDP).
  • Maintain the validation documentation archive and ensure it is readily available for audits and inspections.
  • Regularly review and update validation SOPs, work instructions, and templates to align with the latest regulatory and industry standards.

4. Change Control and Impact Assessment

  • Evaluate and approve changes to validated systems, processes, and equipment, ensuring each change undergoes a proper impact assessment.
  • Ensure prompt documentation and investigation of deviations, identifying root causes, and implementing corrective and preventive actions (CAPA).

5. Risk Management

  • Conduct and oversee risk assessments for processes, equipment, and systems, using tools like FMEA (Failure Modes and Effects Analysis) to identify and mitigate risks.
  • Develop and document risk mitigation strategies, ensuring these are implemented effectively and monitored over time.

6. Compliance and Regulatory Readiness

  • Ensure all validation activities are in full compliance with current regulatory requirements, including FDA, EMA, ICH, and WHO standards.
  • Lead validation audits and inspections, presenting documentation and justifying processes to regulatory agencies.
  • Stay updated on regulatory changes and industry advancements, implementing new standards and techniques into validation practices.

7. Cross-Departmental Collaboration

  • Work closely with quality assurance, Project, engineering, and R&D teams to ensure alignment on validation requirements.
  • Collaborate with the Project team to optimize processes and minimize validation downtime.
  • Provide technical support and guidance to other departments for validation-related concerns, ensuring smooth project execution.

8. Project Management and Coordination

  • Coordinate with project managers and stakeholders to integrate validation activities into the overall project plan.
  • Ensure validation activities align with project milestones, identifying and addressing potential delays.
  • Manage resources effectively, ensuring availability of materials, tools, and personnel for timely validation.
  • Review and analyze validation data, confirming that it meets the acceptance criteria and quality standards.
  • Prepare and present regular validation status reports for HOD/ management, providing insights into key milestones, issues, and improvements.

Preferred candidate profile


B.Tech , Chemical Engineer / Instrumentation Engineer with 6-7 Years experience in Validation , Commissioning and Documentation in API /Bulk Pharma Industries


Skills required :

  • Effective Communication
  • Presentation
  • Pharma Knowledge
  • Team building
  • Basic Technical knowledge
  • Computer Proficiency





Employment Type: Full Time, Permanent

Read full job description

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What people at Polmon Instruments are saying

What Polmon Instruments employees are saying about work life

based on 102 employees
70%
93%
40%
100%
Strict timing
Monday to Saturday
Within country
Day Shift
View more insights

Polmon Instruments Benefits

Job Training
Free Transport
Health Insurance
Soft Skill Training
Team Outings
Education Assistance +6 more
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