Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Sr director vacancy is available at Teva Pharmaceuticals. Please go through the details and apply online for MSc Chemistry Pharmacy job.
Location: Goa, India, 403722
Job Id: 45094
Position Summary for MSc Chemistry Pharmacy job –
You will insure that a Quality Management System is in place, securing compliance of activities and supporting continuous improvement. You are an active member of the Site Leadership Team reporting into the VP Quality SMSO, and strong Quality partner to the Site General Manager, leading the entire Quality Organization at Goa Site.
- Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
- Ensure a current Quality Management System is in place and continuously improved
- Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
- Most senior professional and independent decision maker authority on product quality and potential market actions
- Assess and Mitigate Risks– Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
- Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
- Manage Quality Data–Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance.
Long Description –
- Direct Quality Control– Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
- Promote a Sustainable Culture of Quality—Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
Maintain strong partnership with site leadership team
- Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
Provide effective Quality leadership during internal, customer and Health Authority inspections
- Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically.
- Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.
Short Description of MSc Chemistry Pharmacy job-
Minimum of 10 years of pharmaceutical manufacturing site quality operations and leadership experience, including:
- Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process
- High level of understanding of manufacturing, packaging, technology transfer, cGMPs, FDA, EU, ICH guidelines as well as CMC content of regulatory submissions
- Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types
- Experience preparing and/ or leading regulatory authority GMP and pre-approval inspections, specifically US FDA and EMA inspections Deep knowledge of Quality Systems
- Experience leading, inspiring and coaching large teams
- Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
- Must have adequate knowledge of Quality best practices
- Must have adequate practical knowledge of pharmaceuticals manufacturing and control
Must have adequate practical knowledge of analytical techniques and microbiological principles
- Must have practical knowledge of pharmaceutical cross-functional operations (e.g., Supply Chain, Engineering), product and tech transfer
- Basic Knowledge of OPEX principles
- Good knowledge of environmental, health and safety requirements for laboratories and quality operations.
- Master or equivalent degree in Chemistry, Biology or Pharmacy is required
Hello friends, Here are some expected interview questions and answers attached. Please go through the same during your preparation for MSc Chemistry Pharmacy job. All the best!!!
Question 1: Can you describe your experience in leading a Quality organization at a pharmaceutical manufacturing site?
Answer: I have over 10 years of experience in leading Quality operations at pharmaceutical manufacturing sites. In my previous roles, I have been responsible for overseeing various areas such as Quality Control, Microbiology, Quality Compliance, Quality Systems, and Quality Assurance Operations. I have ensured the implementation and continuous improvement of a robust Quality Management System to comply with cGMP requirements and registered specifications. I have also been the most senior decision-maker authority on product quality and have taken actions to mitigate risks and ensure safe and effective products reach the market. Overall, I have led the entire Quality Organization, collaborating closely with site leadership and cross-functional teams to achieve quality objectives.
Question 2: How familiar are you with cGMP requirements and major international authorities such as EMA and US FDA?
Answer: I have deep knowledge and understanding of cGMP requirements of both local authorities and major international authorities like EMA and US FDA. I have worked in highly regulated environments and have consistently ensured compliance with these regulations. I am well-versed in the manufacturing, packaging, and technology transfer processes, as well as FDA, EU, and ICH guidelines. I have also led and participated in regulatory authority inspections, specifically US FDA and EMA inspections. My expertise in cGMP requirements and regulatory guidelines allows me to effectively drive quality operations and ensure compliance at all times.
Question 3: How have you created and maintained a culture of enhancing quality throughout a pharmaceutical manufacturing site?
Answer: Creating and maintaining a culture of enhancing quality is essential for sustained success. In my previous roles, I have focused on promoting a sustainable culture of quality throughout the entire site operation. I have fostered an environment where open communication is encouraged, and employees are empowered to present new ideas for quality improvement. I have implemented initiatives such as quality training programs, quality awareness campaigns, and regular quality forums to engage employees at all levels. By recognizing and rewarding individuals and teams for their contributions to quality enhancement, I have built a culture where everyone takes ownership of quality and strives for continuous improvement.
Question 4: How do you ensure effective collaboration with the site leadership team and other cross-functional departments?
Answer: Collaboration with the site leadership team and cross-functional departments is crucial for aligning quality objectives with overall business goals. I establish strong partnerships by actively engaging with the site leadership team, Supply Chain, Project Management, R&D, MS&T, and Commercial teams. I participate in regular meetings, provide quality insights and recommendations, and ensure that quality considerations are integrated into project timelines and objectives. I also facilitate effective communication channels and promote cross-functional collaboration to address quality-related issues and drive improvements. By fostering a collaborative approach, I ensure that quality is a shared responsibility across the organization.
Question 5: How do you approach budget management and resource utilization for Quality operations?
Answer: Managing the budget and resources for Quality operations requires careful planning and optimization. I have experience in planning, managing, and monitoring the annual Quality Operations budget, ensuring the allocation of resources in the most efficient manner. I prioritize investments based on critical quality needs and align them with business priorities. I closely monitor resource utilization and identify opportunities for optimization without compromising quality objectives. By implementing efficient processes, leveraging technology where applicable, and regularly reviewing resource performance, I strive to achieve maximum efficiency and cost-effectiveness for the Quality organization.