Location: Toansa, Punjab, India - Category: Quality
Head - Quality
Head – Quality is responsible for all regional quality operations for providing strategic direction & guidance on quality system & GMP compliance and to lead all customer & regulatory audits. To monitor QA/QC teams on critical quality issues for ensuring timely & accurate product release. To ensure that finished products provided to market are as per company specification and in compliance with applicable pharmacopeias as well cGMP/GLP/ICH/USFDA/ISO guidelines.
Key Individual Accountabilities:-
- Lead site quality teams on product quality issues and on running business requests for GMP support.
- Lead site quality review process & direct improvement actions or compliance related issues mitigation in timely manner.
- Review all major capex projects & support on GMP advice related to design, qualification & timely validation of products/ projects.
- Ensure Maintenance & improvement of BU quality system defined in International policies & GSOPs through participation & contribution as reviewer.
- Provide guidance to MT on any changing GMP requirements, which require changes in current BU implementation level.
- Represent management in site regulatory inspections and provide support for customer audits.
- Provide guidance to business on GMP requirements for new product clusters.
- Oversee regular audit of regional sites (customer) and present GMP compliance status to management.
Key Shared Accountabilities:-
- Ensuring changes proposed are reviewed for Quality aspects and ensuring compliance to legal requirements.
- Promoting SHE culture in organization.
- Ensuring risk analysis for each activity is done.
- Reporting all incidents & encouraging team to report same.
- Post-Graduate in Science.
- Minimum 18 years of relevant experience in Pharmaceutical industry (API industry preferred)
- In depth knowledge of cGMP and regulatory requirements.
- Experienced and Certified GxP auditor
- Prior experience in similar roles with good organization.
- International exposure and ability to manage cultural differences.
- Ability to obtain commitment on required improvements from organization’s manufacturing sites and good communication and interpersonal skills.
- Proven track record of executing and implementing major projects at global level Ability to execute holistic & global CAPA
Truly global work environment.
High performance culture.
Ability to make a difference.
Best in class compensation.