Assistant Manager - Process & Documentation ( Automation)

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