Validations Job For 1-8 Year Exp In Gurdev Singh Ahluwalia (proprietorship Of
- Gurdev Singh Ahluwalia
- 1 - 8 Years
- Vadodara
- 4 years ago
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Job Description
Hands on experience in GMP and handling compliance of API facility and designs in regulated environment of pharma domain.Experience in Computer System Validation (CSV)
To participate in the process validation activities, review the change controls and participate in the investigations.
Annual validation/ requalification planning & execution review.
Review of HVAC & Water Plant qualification related documentation.
Good understanding & experience of good documentation practises, cGMP, ICH guidelines.
Good Communication & Interpersonal Skills.
To prepare validation protocol.
To compile the Process Validation result and prepare process validation summary report.
Execute Installation Qualification, Process Qualification, Cleaning and process validation.
Responsible for supporting LIMS implementation and on-going administration
To prepare CSV documentation, Plans, Protocols and Reports
To execute and report validation protocols in accordance with appropriate regulations for quality, health and safety.
To ensure assigned validation exercises are conducted in a timely manner and in compliance with cGMP and project milestones.
To liaise effectively with other departments.
To qualify as necessary, API manufacturing plant, production systems and processes.
To participate in Change Control assessments and project meetings to ensure the compliant status of affected equipment is not compromised.
To portray the professional image of Sanofi at all times.
To review and approve protocols and reports from other departments/companies.
Qualification/validation of packaging and labelling equipment.
To perform Risk Assessments as necessary.
To participate in corporate, regulatory and internal audits as necessary.
To participate in FAT inspections as required.
To review/validate GMP spreadsheets as required.
To maintain up to date knowledge of regulatory standards
To liaise with MTS and Manufacturing in respect to qualification of control systems.
Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
In addition to the contractors, manage other validation team member(s), including their performance, development, training and compliance.
As a key member of the Quality team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the programme.
Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
Train team members in procedures relating to validation as required.
Participate actively in the preparation for the Manufacturers Licence as directed by Head of Quality.
Understand the production schedule, and work closely with Manufacturing and Engineering to build a qualification schedule that delivers minimum interruption to manufacturing output.
Work in a safe manner, ensuring full compliance to HS&E policies at all times. Participate in and respond to inspections by Regulatory Authorities including MHRA and FDA, representing the validation function.
Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently.
Establish and maintain strong relationships with cross functional departments including Manufacturing, CMC, Engineering and Regulatory groups
Actively maintain and update knowledge and expertise of current developments, standards and operating practices within the ATMP and pharmaceutical industries.
Employement Category:
Employement Type: Full timeIndustry: Pharmaceutical
Functional Area: Marketing Research & Analysis
Role Category: Head
Role/Responsibilies: Validations Job For 1-8 Year Exp In Gurdev Singh Ahluwalia (proprietorship Of
Contact Details:
Company: Gurdev Singh AhluwaliaLocation(s): Vadodara
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Keyskills: Validations Validation Process Validation Compliance Validation Certification Validation Engineer alityQuality Control
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₹ 100000 - 800000 IN
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