Quality Control Head
18 hours ago
Accountable for assuring the supply of high quality, GMP compliant drug products, define operational strategy for quality control system at site, facilitate in finalizing quality control goals, objectives and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements, conduct effective review of the team and portfolio and provide direction and guidance to the team and develop team competence with the objective of ensuring Quality of products manufactured and released with adherence to GMP norms and timelines.
The incumbent will assure individual compliance with all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Areas of Responsibility
Key responsibilities:
- Assess and ensure compliance to QC regulatory requirements and track quality metrics and drive them down.
- Effectively manage the site Quality Control activities and resources necessary to smoothly run the QC operation including release of incoming materials, drug products and facilitating stability studies of commercial products as per cGMP requirement and regulatory commitments.
- Ensure analytical methods are validated/transferred at site laboratory as per cGMP requirement and regulatory commitment.
- Monitor and review investigations and QMS with adequate CAPA to minimize errors.
- Design, implement and reviews with QC section heads for compliance related to SOPs, policies, standards and quality systems.
- Design and execute continuous improvement initiatives in the site to enhance compliance, drive efficiencies and cost effectiveness.
- Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional/global quality policies/standards.
- Assure all time readiness of site for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams.
- Facilitate arrangement of all the resources required to QC laboratory to achieve desired productivity, SLA defined as per KPI by continual improving the process excellence.
- Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.
- Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
- Ensure that performance issues are managed in a consistent and timely manner.
- Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
- Responsible for ensuring compliance to regulatory requirements on product, process and release procedures.
- Responsible for ensuring smooth collaboration with all Sun Pharma sites and leveraging synergies.
Roles
Additional responsibilities can be assigned as required
Job Scope
Internal Interactions (within the organization)
External Interactions (outside the organization)
Geographical Scope
Financial Accountability (cost/revenue with exclusive authority)
Job Requirements
Educational Qualification
Science or Pharmacy Graduates or Equivalent
Specific Certification
Skills
Experience
20+ Yrs (OSD + Injectables) with regulatory experience
#J-18808-Ljbffr-
Senior General Manager
1 week ago
Indiana, United States Sun Pharmaceutical Industries, Inc. Full timeTitle: Senior General Manager - Site Quality Head Job Role: Senior General Manager - Site Quality Head - Injectables Grade: GM / Sr.GM POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and...
-
Senior General Manager
6 days ago
Indiana, United States Sun Pharmaceutical Industries, Inc. Full timeTitle: Senior General Manager - Site Quality Head Job Role: Senior General Manager - Site Quality Head - Injectables Grade: GM / Sr.GM POSITION SUMMARY Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and...
-
Head of Quality
18 hours ago
Shreveport, LA, United States DSJ Global Full timePosition Overview The Head of Quality is responsible for leading and improving the plant's quality assurance, control, and management systems. This role ensures that all products meet established quality standards by developing and implementing quality management systems and managing the QA/QC team. Key Responsibilities Oversee product quality and develop...
-
Head of Quality
4 weeks ago
Memphis, TN, United States DSJ Global Full timePosition OverviewThe Head of Quality is responsible for leading and improving the plant's quality assurance, control, and management systems. This role ensures that all products meet established quality standards by developing and implementing quality management systems and managing the QA/QC team.Key ResponsibilitiesOversee product quality and develop...
-
Head of Quality
2 days ago
St. Albans, VT, United States X4 Life Sciences Full timeExciting opportunity: Head of Quality/ Qualified Person for a growing pharmaceutical manufacturer. If you are a seasoned Quality professional, based in or around St Albans, Hertfordshire, with leadership experience in the pharmaceutical industry, this role might be for you! This role will be on-site 5 days per week. Your Responsibilities: Responsible to...
-
Head of Finance Controllers
2 days ago
Southampton, MA, United States CV-Library Full timeHead of Finance Controllers Basingstoke£120K per annum Our client is seeking a Head of Finance Controller to join their team in Basingstoke. Working closely with the CFO and supporting the Financial Controllers throughout Europe, you will supervise the existing team of country controllers, develop the Group Financial Planning & Analysis function, and manage...
-
Head of Quality Control
2 days ago
Peachtree City, GA, United States Gerresheimer AG Full time650 Highway 74 South, United States | Peachtree City | Full-time Job Description • Personnel management with all included individual tasks (initiate disciplinary measures, appraisal of employees, personnel development, etc.)• Ensuring the induction, appraisal and development of employees by the subordinate managers• Long-term planning with regard to...
-
Head of Quality
19 hours ago
, NC, United States Hobson Prior International Ltd Full timeHobson Prior is seeking a Head of Quality for a role in the medical devices sector. This position focuses on ensuring high standards of quality and compliance for medical products. The successful candidate will be responsible for maintaining quality systems, managing audits, and leading a team to uphold product safety and effectiveness. Responsibilities: ...
-
Associate Director
8 hours ago
Portsmouth, NH, United States Lonza Full timeUnited States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
-
Indiana, Pennsylvania, United States Quality Process Services Full timeJob Title: Valve TechnicianEstimated Salary: $70,000 - $90,000 per yearAbout UsQuality Process Services is a leading provider of quality assurance solutions in Indiana, PA. We are dedicated to delivering exceptional services and ensuring the highest standards of quality.Job DescriptionAs a Valve Technician at Quality Process Services, you will be responsible...
-
Coordinator, Quality Control
3 days ago
Baden, PA, United States Giant Eagle Full timeCoordinator, Quality Control at Giant Eagle summary: As a Quality Control Coordinator, you will oversee food safety and quality, ensuring compliance with regulations and company policies. Your role involves conducting inspections, monitoring critical control points, and providing training to production staff on food safety procedures. With a focus on...
-
Coordinator, Quality Control
3 days ago
Freedom, PA, United States Giant Eagle Full timeCoordinator, Quality Control at Giant Eagle summary: As a Quality Control Coordinator, you will be responsible for ensuring food safety and quality, promoting continuous improvements, and ensuring compliance with regulations and safety policies. You will perform inspections, report issues, evaluate problems, and assist in quality training for production...
-
Head of Quality Assurance
2 days ago
Austin, TX, United States Unreal Gigs Full timeIntroduction: Are you a detail-oriented leader with a passion for ensuring that every product released meets the highest standards of quality? Do you have the strategic vision to develop and implement robust QA processes while also leading a team to excellence? If you’re someone who thrives on making sure that every piece of software is flawless, then our...
-
Head of Quality Management
18 hours ago
Middletown, DE, United States Datwyler Full timeLocation: Middletown, DE, US, 19709; Pennsauken, NJ, US, 8110 In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as...
-
Quality Control Tech
4 weeks ago
Emmaus, PA, United States Heidelberg Materials US, Inc. Full timeAutoReqId: 21151BR Pay Class: Salaried Non-Exempt Department: Quality Job Posting: The Role and the Company Heidelberg Materials provides the materials to build our future. Our future is sustainable. Our future is digital. And it goes way beyond cement, aggregates and ready-mixed concrete. Heidelberg Materials North America, previously known as Lehigh...
-
Quality Control Technician
4 weeks ago
York, PA, United States Elgen Staffing Full timeOur client, a global leader in packaged good solutions, has an immediate need for an experienced Quality Control Technician, to join our winning team in York. Interested in this role You can find all the relevant information in the description below. Our candidate of choice will ensure quality and operational compliance to the customer and CP...
-
Coordinator, Quality Control
1 week ago
Freedom, PA, United States Giant Eagle Full timeJob SummaryAs a Quality Control Coordinator, your main responsibility will be to ensure food safety and quality of the food. Also, you will promote continuous and sustained improvements by ensuring compliance with all regulations and company safety policies and proceduresJob DescriptionExperience Required: 1 to 3 yearsExperience Desired: HACCP/FSMA Training...
-
Director - Head of Global Sanctions Controls
2 days ago
New York, NY, United States MUFG Bank, Ltd Full timeDirector - Head of Global Sanctions Controls Do you want your voice heard and your actions to count? Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world’s leading financial groups. Across the globe, we’re 120,000 colleagues, striving to make a difference for every client, organization, and community we serve. We stand...
-
Head of Controlling
18 hours ago
Cincinnati, OH, United States Givaudan Fragrances Full timeJoin us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with kindness and humility, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions that make people look and feel good. There's much to learn and many to learn from, with more than 16,000...
-
Head Start Quality Assurance Manager
16 hours ago
Bethesda, MD, United States ISN Corporation Full timeCompany Description Headquartered in Bethesda, Maryland, ISN Corporation is a nationwide provider of specialized professional services to Federal government agencies. ISN's portfolio includes work with over 100 Federal agencies. ISN Corporation has been awarded a place in the Washington Business Journal's list of the 50 Fastest Growing Government...