2 0 plus years of relevant experience in large molecules/ vaccines/ biologics industry
In depth knowledge of and ability to interpret and apply GMP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
Experience in planning and conducting GMP and GLP audits
Experience with regulatory inspections and inspection readiness
Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
Strong team player with demonstrated track record of success in a cross‐functional team and fast moving environment
Experience in authoring and compiling data for regulatory submissions (IND etc )
Excellent organization and planning skills
Proven ability to build, lead and grow a team of technical specialists
Strong strategic, data driven analytical skills with ability to integrate complex considerations in formulating a pragmatic approach towards problem solving
Excellent cross functional and stakeholder management skills and ability to develop strong relationships across functions, senior leaders and key stakeholders
Strong communication and interpersonal skills including ability to prepare and deliver effective presentations and provide information to influence major decisions
Must have a positive attitude and be adaptable to a dynamic "startup" environment without losing focus on business goals Piramal Success Factors:
JOB RESPONSIBILITIES:
Formulate compliance strategy for the company as per the global quality and regulatory expectations and provide advice for all activities and programs
Assess GMP and GLP compliance risk areas and develop and implement risk mitigation
Develop and prioritize an audit strategy for all programs
Plan and lead GMP and GLP compliance and audits to determine compliance status and identify compliance risks
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
Manage regulatory authority inspections and the coordination of responses to resolve inspection findings if any
Lead GMP/GLP training of functional areas and develop appropriate training for personnel
Design, Develop and implement standards, policies, and procedures for GMP and GLP as per regulatory compliance, in line with client requirements
Create and Participate in quality and compliance improvement initiatives within Yapan
Provide guidance, interpretation, and information on GMP and GLP regulations, standards, and quality systems
Prepare internal Quality reports, and provide input for external partners reports and/or regulatory filings
Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
Undertake regular internal and process audits of the Quality Management System of the organization
Ensure ongoing compliance with the Quality Management System
Report and escalate compliance issues to management, including requests for directed audits
Introduce new systems and proced
Benefits
Vision insurance
Additional Information
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Division
Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Head Quality Job Description
The incumbent will be responsible for leading the overall Quality function for the organization. The Head
Quality will guide and lead members of the Quality Assurance (QA) and Quality Control (QC) teams to deliver
as per the corporate goals, projects, plans and timelines.
This position requires demonstrated ability to work effectively as both scientific/technical and people leader,
manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along
with excellent interpersonal and presentation skills.
The candidate should be self
sufficient in planning and execution along with applying innovative thinking to
improve effectiveness and efficiency of the function. A person in this role is expected to engage and interact
frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders. QUALIFICATION:
Postgraduate or PHD in a relevant field
Piramalpharma · Hyderabad, India