1. Question: Can you give an example of how you led a team to achieve a challenging goal?
At PCI Pharma Services, I was tasked with improving the pack-per-head capacity in our
packaging operations, which was falling behind target.
My goal was to increase capacity while reducing labor costs and ensuring compliance
with quality standards.
I led a project to implement auto-plugging and capping in the packaging process. I
redesigned workflows and trained the operators on the new system.
This increased the pack-per-head capacity by 4,000 units and reduced the workforce
requirement, saving the company €19,000 annually.
2. Question: Tell me about a time you managed a quality issue effectively.
During my time at Indus Pharma, I noticed significant sedimentation in a pharmaceutical
product, which was leading to product rejection.
My responsibility was to identify the root cause and implement corrective measures to
maintain product quality.
I worked closely with the formulation and process engineering teams, conducted trials,
and optimized both the formulation and process parameters.
The sedimentation issue was resolved, resulting in a financial gain of €3,000 and
ensuring product consistency.
3. Question: Can you describe a time when you optimized a process to save costs?
At GlaxoSmithKline, the secondary packaging process was complex and generated
unnecessary waste.
I was tasked with simplifying the process to reduce waste and improve efficiency.
Using Lean and Kaizen principles, I conducted workshops with the team to eliminate
non-value-added steps and redesigned SKUs to eliminate components like rubber
bands.
The initiative saved €28,793 annually and completely eliminated non-hazardous waste.
4. Question: How have you ensured compliance and maintained quality in your operations?
At PCI Pharma Services, an Ambisome batch was packed with different lot numbers,
creating a compliance risk.
I needed to investigate and prevent similar incidents in the future.
I conducted a root cause analysis, identifying operator error and inadequate training as
key issues. I implemented refresher training and enforced stricter inspection protocols.
Compliance was restored, and future errors were avoided, reinforcing a culture of
quality and accountability.
5. Question: Describe a time when you led a change in a fast-paced environment.
At DOX Pharma, I identified inefficiencies in manual batch records that were causing
delays in production.
My objective was to modernize the system and improve real-time tracking of
production.
I spearheaded the introduction of a paperless batch manufacturing and packing records
system. I also trained over 80 employees to use the new system.
This reduced deviations, lowered costs by 30%, and improved real-time monitoring of
production.
6. Question: Share an example of how you handled a crisis during production.
At PCI Pharma Services, leaking bottles were identified during the Fintapla packaging
process, threatening to halt production.
I had to resolve the issue quickly to prevent delays and losses.
I segregated leaking and low-weight bottles, ensured unaffected bottles were packed,
and implemented a torque tester at the end of the line to prevent future leaks.
The crisis was averted without major delays, and the new system ensured consistent
quality moving forward.
7. Question: How have you used technology or ERP systems to improve processes?
At DOX Pharma, I noticed that manual monitoring of batch records was time-consuming
and error-prone.
I was tasked with finding a way to improve efficiency and accuracy in the process.
I led the implementation of an ERP system for real-time batch monitoring. I coordinated
with IT and trained the team to use the system effectively.
The new system significantly reduced errors, streamlined processes, and improved data
visibility across departments.
8. Question: Can you share an instance when your innovation led to significant
improvements?
During my role at Indus Pharma, I encountered persistent sedimentation issues in
Erythromycin suspension, leading to high rejection rates.
I needed to find a creative solution to fix the issue while maintaining product integrity.
I collaborated with the formulation team to tweak the process parameters by changing
the varied concentration of stabilizer to a specific concentration of stabilizer and
conducted trials to optimize stability.
Sedimentation was eliminated, product consistency improved, and €3,000 in financial
losses were recovered.
Solving Operational Problem: Deviations & RCA
Question 1 Can you describe a time you solved a recurring operational deviation?
During packaging of Clobevate Ointment, incorrect expiry dates were embossed on several
batches due to procedural lapses in in-process checks and failure to follow established SOPs.
I was responsible for ensuring procedural compliance and reducing the likelihood of recurring
issues in the future batches.
I conducted a root cause analysis and identified gaps in SOP clarity and team training. I revised
the SOP to include a mandatory dual verification process for expiry date checks and organized
refresher training sessions for both production and quality assurance staff.
This change eliminated incorrect embossing issues in subsequent batches and improved overall
compliance. Additionally, these efforts reduced rework and wastage by 30%, saving significant
time and resources.
Describe a time you dealt with a quality issue in packaging. How did you resolve it?
On our packaging line for Ambisome, we discovered that a batch was packed with leaflets
containing a different lot number. This posed a significant compliance risk.
My responsibility was to identify the root cause, prevent recurrence, and ensure the batch met
all regulatory standards.
Upon investigation, we found that the operator had missed checking the leaflet lot numbers
and wasn’t fully trained on the Booking In process. I took two corrective actions: (1) Inspected
all attached leaflet samples to ensure compliance and (2) arranged refresher training for the
operator to reinforce their understanding of quality checks.
The issue was resolved without further non-compliance. The operator’s improved awareness
has since prevented similar errors, maintaining our packaging standards.
Can you share an example of improving efficiency in your packaging process?
During the packaging process for Fintapla, we noticed leaking bottles from the cap side, which
was traced to insufficient torque applied during capping.
I needed to address this issue quickly to avoid wasting bottles and prevent downtime.
I implemented a three-step approach: (1) Segregated all low-weight and leaking bottles, (2)
ensured only defect-free bottles were packed, and (3) introduced a cap torque tester at the end
of the line to validate proper sealing.
These actions not only eliminated leaks but also increased our throughput by 15%, as there
were fewer disruptions. The torque tester is now a standard practice, ensuring consistent
quality.
Tell me about a time you managed a deviation in standard operating procedures.
We discovered that 500 Voxzogo vials were acclimatized for only 15 minutes instead of the
required 30 minutes before labeling.
My role was to assess the impact, correct the deviation, and ensure SOP adherence moving
forward.
First, I conducted a risk and impact assessment, verifying that there was no condensation on
the vials, and confirmed the packaging room’s temperature was stable at 23°C. Then, I (1)
inspected the samples for label adhesion and batch details, (2) updated the IPC checklist to
reflect the correct acclimatization conditions, and (3) implemented a visual alarm system to
ensure proper timing.
This process improvement significantly reduced the likelihood of future acclimatization errors
and ensured uninterrupted compliance with GMP standards.
Describe a time when you introduced a process improvement in manufacturing.
There was recurring downtime on the packaging line due to inconsistent torque applied to
bottle caps, leading to leaks.
I was tasked with implementing a sustainable solution to improve productivity and product
quality.
I conducted a root cause analysis and identified that manual torque application varied too
much. I introduced an automated cap torque tester at the end of the line, which standardized
the process. Operators were also trained to monitor the tester’s output.
The new system reduced leak-related downtime by 20% and improved product reliability,
earning positive feedback from QA and production teams.
General process improvements, cost-saving measures, or productivity enhancements.
Question 1 Can you describe a time you improved a process at work?
At GSK, the manufacturing process for Bactroban Cream involved three steps and a batch size of
only 250 kg, which resulted in extended manufacturing hours and higher bulk wastage.
My responsibility was to simplify the process, increase efficiency, and reduce production costs
without compromising quality.
I proposed and implemented batch upsizing from 250 kg to 500 kg, utilizing a 1000 kg
manufacturing vessel. This reduced the manufacturing steps from three to two and streamlined
the process.
This improvement led to a significant reduction in manufacturing hours and bulk wastage from
3% to 1%. In terms of financial savings, the company saved Rs. 215,713 in 2012 and Rs. 266,469
in 2013.
Question 2 Give an example of when you introduced a cost-saving measure.
At GSK, Our team was tasked with reducing costs related to labeling operation in production
department.
I needed to find an alternative solution that would eliminate the need for outer labels and reduce
glue inventory while ensuring compliance with labeling standards.
I introduced the use of a rubber stamp for labeling C/boxes instead of using adhesive outer
labels. This change required training the team to transition to the new method and ensuring
consistent output quality.
This simple but effective solution completely eliminated the need for outer label and glue
inventories, reducing ergonomic risks in the process. The company achieved financial savings of
2000 Euro.
Question 3 Describe a time when you increased productivity in your workplace.
At GSK, the production of Dermovate NN Ointment involved multiple steps include transfer of
bulk into the holding vessesls, passess the API slurry through the colloidal mills and then again
transfer the Bulk and API slurry into the manufacturing vessel, which consumed time and labor
hour, as well as increase ergonomic risk.
My goal was to streamline the process to reduce labor hours, simplify operations, and improve
safety.
I aligned the colloidal mill directly to the manufacturing vessel, enabling a single-step process
instead of the previous two-step procedure. Additionally, I trained operators to handle the new
workflow effectively.
This improvement not only reduced labor hours significantly but also eliminated ergonomic risks
and slip/trip hazards. It simplified the workflow, ing in safer and faster production.
Question 4 Tell me about a time you implemented a change that supported environmental or
safety improvements.
At GSK, the process of transferring bulk Dermovate cream involved a pneumatic piston pump,
which posed ergonomic risks and potential slip/trip hazards for operators.
I was tasked with finding a safer and more efficient method for bulk transfer.
I introduced a recirculation pump to transfer the bulk, replacing the pneumatic piston pump.
This solution required adjustments in equipment layout and operational training for the staff.
The new system completely eliminated ergonomic risks and slip/trip hazards. It also streamlined
the process, making it safer and easier for operators to handle, while maintaining consistent
product quality.
Question 5 Can you give an example of a time you enhanced equipment utilization?
The utilization of manufacturing equipment for ORS was suboptimal due to the smaller batch
size of 175 kg, leading to extended manufacturing and filling hours.
My role was to improve equipment utilization and minimize production time while maintaining
product quality.
I upsized the batch from 175 kg to 500 kg, transitioned the process from manual packing to
online packing, and streamlined testing requirements to reduce documentation and lab testing.
These changes reduced manufacturing and filling hours significantly, with a savings of 88 hours
in filling and 532 hours in packaging. The changes also decreased hazardous waste and rejections
while improving process efficiency.
Question 10 Describe a time when you implemented automation to improve efficiency.
The manual packing operation for Nedax Plus Lotion was slow and required significant
manpower, limiting productivity to 16,000 packs per day.
I was tasked with finding a way to increase productivity and streamline the process.
I implemented an auto-plugging/capping machine for pre-printed bottles, which automated the
packaging process and improved workflow.
Productivity increased from 16,000 to 20,000 packs per day, and the number of packs per person
rose from 1,350 to 2,500. The automation significantly improved manpower utilization and
process flow.
Question 11 Can you share a time you solved a safety issue in the workplace?
The process of transferring API slurry during manufacturing involved manual handling and
pneumatic piston pumps, creating ergonomic risks and potential slip/trip hazards.
My responsibility was to eliminate these risks while maintaining operational efficiency.
I introduced a recirculation pump to transfer the slurry safely, eliminating the need for manual
handling and elevated pump operations.
The new method completely eliminated ergonomic risks and slip/trip hazards, creating a safer
work environment and improving process efficiency.