MDS Associate Manager Job For BSc Biology, Microbiology – Apply Online
MDS Associate Manager Job For BSc Biology, Microbiology – Apply Online. MSD BSc Biology, Microbiology job opening. Interested and eligible applicants can check out all of the details on the same below
If you are wondering what kind of interview questions can be asked for the role of Associate Manager, Quality Complaint Management, then check out some of the possible interview questions below along with the answers.
Post Name – Associate Manager, Quality Complaint Management
Location – Pune, Maharashtra, India
Job ID: R232891
Job Description
Associate Manager, Quality Complaints Management
This position is responsible for executing Product Quality Complaint policy and guidance to assure product quality complaint management processes are in compliance with regulatory expectations. Responsible for receipt and handling of product quality complaints.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time
, across the globe.- Manage routine product quality complaints and/or adverse events, including but not limited to:
- Provide notification of product quality complaint(s) and/or adverse events to the External Partner (EP) and request investigation initiation
- Coordinate investigation with EP site, to ensure due date and deliverables are met.
- Coordinate complaint sample delivery to EP site
- Review and approval of EP complaint investigation report
- Enter investigation details in our complaint management system.
- Coordinate supporting investigations with upstream sites as needed.
- Routing and management of complaint record extensions as needed.
- Issue escalation to the relevant Focus Factory Team members and/or Complaints CoE
- Attend monthly EQA Complaints CoE meetings as required.
- Trending of complaints by products and complaint category
- Participate/provide support for audit/inspections related to complaint handling as appropriate.
Qualifications:
- A degree in science, engineering or any relevant technical discipline (BS biology, microbiology, pharmacy, chemistry, chemical engineering, or equivalent preferred).
- Previous experience in the pharmaceutical industry with knowledge of Quality Systems and Quality Assurance including global GMP Quality Systems and regulatory requirements preferred.
- Experience in pharmaceutical manufacturing of API/DS and/or oral solid dose and/or biologic/sterile products.
- Previous experience managing product quality complaint and/or adverse event investigations.
- Problem solving & continuous improvement mindset.
- Ability to respond to non-standard requests from Internal stakeholders and External Partners; investigates with assistance from others as needed.
- Ability to work across boundaries with both Internal stakeholders and External Partners
- Communicates easily in English both verbally and in writing.
- Knowledge of External Manufacturing management, supply chain, and operations (advantageous but not required)
- Background in pharmacy / hospital setting / laboratory advantageous but not essential.
- Background in manufacturing investigations e.g. deviations, out of specifications etc. (advantageous but not required)
- Previous experience in pharmacovigilance (advantageous but not required)
- Background in manufacturing investigations e.g. deviations, out of specifications etc. (advantageous but not required)
- Previous experience in pharmacovigilance (advantageous but not required)
Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
If you are wondering what kind of interview questions can be asked for the role of Associate Manager, Quality Complaint Management, then check out some of the possible interview questions below along with the answers.
- How would you ensure compliance with regulatory expectations in the management of product quality complaints? Can you describe the steps you would take to execute the Product Quality Complaint policy effectively?
Answer: To ensure compliance with regulatory expectations, I would follow established procedures for handling product quality complaints. This includes promptly notifying the External Partner (EP) and initiating an investigation, coordinating with the EP site, reviewing and approving the EP complaint investigation report, entering investigation details in the complaint management system, and managing complaint record extensions as necessary. I would also participate in EQA Complaints CoE meetings and conduct trending analysis of complaints by products and complaint categories.
- Can you provide an example of a situation where you had to coordinate investigations with upstream sites? How did you ensure effective collaboration and timely resolution of the complaint?
Answer: In a previous role, we received a product quality complaint that required investigations at multiple sites within the manufacturing network. I initiated communication with the relevant upstream sites, clearly outlining the complaint details and requesting their cooperation in the investigation. I ensured regular updates, established clear timelines for deliverables, and facilitated effective collaboration by providing necessary support and resources. Through proactive communication and coordination, we were able to resolve the complaint within the expected timeframe.
- How do you approach problem-solving and continuous improvement in the context of product quality complaints? Can you share an example where you identified an improvement opportunity and implemented a solution?
Answer: I approach problem-solving and continuous improvement by analyzing root causes, gathering relevant data, and involving cross-functional teams. In a previous role, I noticed a recurring issue related to a specific product complaint category. I initiated a detailed analysis to identify the root cause and collaborated with stakeholders to develop an improvement plan. By implementing process modifications and providing additional training to relevant personnel, we successfully reduced the occurrence of similar complaints, leading to improved product quality and customer satisfaction.
- How do you ensure effective communication with internal stakeholders and external partners in the management of product quality complaints? Can you share an example of a challenging communication situation and how you resolved it?
Answer: Effective communication is vital in complaint management. In a previous role, I encountered a situation where there was a miscommunication between our internal stakeholders and an external partner regarding the investigation timeline for a critical complaint. To resolve this, I immediately initiated a conference call with all parties involved to clarify the expectations, address concerns, and align on a revised timeline. I emphasized the importance of open and transparent communication, fostering a collaborative environment that allowed us to overcome the challenge and successfully complete the investigation.
- How do you stay updated with regulatory requirements and industry best practices related to complaint management? Can you describe a situation where your knowledge of regulatory requirements significantly influenced your decision-making process?
Answer: Staying updated with regulatory requirements and industry best practices is crucial in complaint management. I actively participate in relevant trainings, workshops, and regulatory forums to stay informed. In a recent case, I encountered a complaint involving a potential product safety concern. Drawing upon my knowledge of regulatory requirements, I immediately escalated the issue to the Complaints CoE and relevant Focus Factory Team members, ensuring timely actions were taken to mitigate any potential risks to patients and comply with regulatory obligations.
Remember to tailor your answers based on your own experience and knowledge of quality complaint management. These sample answers can serve as a starting point for crafting your responses.
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