General Manager
3 weeks ago
A key objective of this role is to oversee entire project lifecycle, ensuring compliance with regulatory standards and company policies. This role involves leading validation activities, coordinating with various departments, and providing technical expertise to ensure successful project execution in India and subsequently in Ireland.
Desired Candidate Profile:Degree in BE in mechanical engineering with 15-18 years of validation experience in FDA-regulated manufacturing environments. Strong communication skills, attention to detail and proficiency in computer skills are essential.Minimum of 15-20 years' extensive experience in project management within the pharmaceutical industry.Proven track record in executing projects from conception to commissioning, with a strong focus on quality, compliance and timely delivery.Excellent leadership skills with the ability to coordinate internal and external stakeholders effectively.In-depth knowledge of project documentation, regulatory requirements, and GMP standards.Experience in vendor management, contract negotiation, and procurement processes.Proficiency in project management tools and software.
Role Requirements:Project Validation Leadership:Lead the project phase of the System Life Cycle approach to qualification.Develop User/Functional Requirement Specifications (UR/FS), Verification Plans and Commissioning protocols.Prepare specifications for purchasing materials or equipment.Execute commissioning and qualification protocols for GMP areas, utilities and equipment.Oversee instrumentation qualification and retirement phase activities.
Vendor Management and Procurement:Identify and engage with world-leading OEMs for project requirements.Finalize contractors, review construction drawings and handle quotations for material procurement.Ensure equipment safety and adherence to regulatory requirements.
Budget and Timeline Control:Control project timeline, budget, and quality to meet organizational objectives.Ensure projects are completed within budgetary constraints and regulatory guidelines.
Compliance & Documentation:Ensure compliance with regulations and company policies.Provide documentation support for document control, change control and validation activities.Conduct Hazard Analysis, Failure Mode Effective Analysis (FMEA) and risk management.
Interdepartmental Coordination:Coordinate with various departments and vendors for data collection and project integration.Prepare and approve User Requirement Specifications (URS) and Facility Layouts.Plan/schedule qualification activities and project execution.
Technical Expertise:Analyze validation test data and identify system problems.Operate computer-assisted engineering equipment.Conduct temperature/humidity mapping studies and engineering experiments.Develop process flow diagrams, material specifications, and standard operating procedures.
Risk Management and Issue Resolution:Anticipate and proactively address potential project risks and issues.Develop mitigation plans to minimize project disruptions.Drive agility in project delivery and continuous improvement.
Functional Skills:Strong understanding of the System Life Cycle approach to qualification.Proficiency in developing validation protocols and documentation.Knowledge of regulatory standards and compliance requirements.Ability to analyze validation test data and propose resolutions.Technical expertise in engineering equipment and experiments.In-depth knowledge of SVP/LVP production and BFS facilities.
Behavioral Skills Required:Excellent communication skills for collaboration and documentation.Attention to detail and precision in following instructions.Proficiency in computer skills, including data entry and analysis.Ability to work as part of a team and coordinate validation activities effectively.Commitment to continuous improvement and staying updated on industry trends.
Important Links:Website:LinkedIn:Instagram:
Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
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