Ls Hireman consulting Pvt Ltd Looking for at Mysore, Karnataka

Ls Hireman consulting Pvt Ltd; Mysuru; On-site; INR 6,00,000 - 9,00,000; Full time

Job summary

Join a forward-thinking company in the pharmaceutical sector, where your expertise in computer system validation and data management will be crucial. This role offers a dynamic environment where you'll manage URS, execute performance qualifications, and ensure compliance with regulatory standards. Collaborate with a skilled team to implement LIMS/SAP systems and oversee quality risk management processes. Your contributions will directly impact the establishment of a green field Pharma facility, making this an exciting opportunity for professionals with a passion for innovation in the industry. If you're ready to take on challenges and drive excellence, this position is for you.

Qualifications

• 6-8 years of experience in Pharmaceutical QC Instrument Data Management.
• Proficient in managing URS and Operationalisation of computer and server systems.

Responsibilities

• Prepare documentation for software qualification and validation.
• Perform system validation and GXP assessments as per regulations.
• Responsible for audits and compliance with safety and health policies.

Skills

Computer System Validation

GXP Assessment

Risk Assessment

LIMS/SAP Implementation

Quality Risk Management

Change Control Management

User Management

Regulatory Compliance

Education

B.Tech/B.E. in Electronics/Telecommunication

B.Pharma in Pharmacy

Specialization in Instrumentation, Mechanical, Computers

Tools

HPLC

GC

SCADA Software

Job description

Job Description:

• Proficient in managing URS and Operationalisation of the Computer, Data backup, server system.
• Perform computer system validation as per 21 CFR Part 11, GAMP5 and Annex 11 and applicable regulations and guidelines.
• Perform GXP assessment and System Classification, 21 CFR Part 11 assessment of analytical software.
• Prepare various documents related to the Qualification of software and instrument/equipment.
• Prepare URS, Validation plan, Functional specification, Performance Qualification, Risk Assessment, traceability matrix and validation summary report for software.
• Review documents and activities related to Installation Qualification, Operation Qualification and other Qualification documents, where relevant.
• Perform Quality risk Management at different stages of Instrument/equipment and software system qualification.
• Execute Performance Qualification for various instrument systems, PC interface, SCADA software.
• Implement LIMS/SAP in the Laboratory.
• Monitor and review information related to User Management, Backup and restoration activities; and escalate any issues.
• Prepare metrics as per applicable regulatory requirements and review with team and supervisor.
• Update software inventory.
• Handle change control related to CSV, documents, infrastructure, SOP ensuring timely closure.
• Responsible as administrator for Firmware based systems i.e. HPLC, GC, Balance, pH Meter etc.
• Raise Discrepancies observed during qualification, evaluate the discrepancies and propose the CAPA actions.
• Interact with Users to address issues identified; and escalate, where relevant.
• Undergo training and adhere to responsibilities as indicated in the SOPs.
• Ensure training binder is updated on an ongoing basis.
• Ensure documents are updated in a timely manner.
• Responsible during audits – represent the department during audits including regulatory inspections.
• Adhere to company policies and procedures related to safety, health and environment.
• Execute any other responsibilities indicated by the management.
• Note: Green field Pharma (API) facility system development/establishment experience is a must.

Qualifications: B.Tech /B.E. in Electronics/Telecommunication, Any Specialization, Instrumentation, Mechanical, Computers, B.Pharma in Pharmacy.

Experience: 6-8 years in Pharmaceutical QC Instrument Data Management.

Job Types: Full-time, Regular / Permanent

Salary: ₹600,000.00 – ₹900,000.00 per year

Ability to commute/relocate:

• Mysore, Karnataka: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Total work: 6 years (Preferred)