Top 100 Quality assurance Interview Questions in Pharma Industry
These are Top 100 Quality assurance Interview Questions in Pharma Industry, these will be helpful for cracking interview for QA personnel in Pharmaceutical industry. This is Part 1 for Q&A, I have created more than 500 Q&A for Interview preparation for Quality Assurance Interview Questions in Pharma Industry you can Read Other Part from the following links:
Part 3
1. First
Column of first row shall left blank for ....................Stamp.
“Master Copy”
Effective date
is the date on which the SOP is issued to concern departments after approval
(TRUE/FALSE)
FALSE
2.
SOP shall be reviewed ...................or
within 30 days before review date.
A) Once in 2 years (Or as per Company Policy)
B) Every Year
C) Once in 5 years
D) None of above
3.
After approval of SOP, Initiating
Department-Head/Designee shall impart the training to all concerned through
approved copy of SOP within ..................
A) 15 days
B) 07 days
C) Same day
D) None of above
4.
A4 size plain white SOP paper shall be used
for SOP printing instead of pre-printed logo paper (TRUE/FALSE)
TRUE
Master SOP’s
shall be retained and controlled by the In-charge/Designee of Quality Assurance
Department. (TRUE/FALSE)
TRUE
5.
Old master SOP shall be retained after
stamping ............... and archived in QA department.
A) Redundant
B) Superseded
C) Controlled
D) Uncontrolled
6.
Distribution record and training record of
SOP’s shall not be kept with respective master SOP(TRUE/FALSE)
FALSE
7.
SOP Number of Redundant SOP shall not be
assigned in future and in SOP index “REDUNDANT” shall be printed at the place
of that SOP(TRUE/FALSE)
TRUE
8.
Authorized QA personnel shall scan each format
and annexure from master SOP and shall keep in system drive in QA
folder(TRUE/FALSE)
TRUE
9.
Who shall be responsible for submission of
filled formats & logbooks to Quality Assurance?
Ans. Executive/Designee of concern
department.
10.
Concerned Departments shall retain scan copy
of SOPs with Formats and Annexure(s) of all departments and other master
documents (TRUE/FALSE)
Ans. FALSE
11.
For issuance of formats user department
shall take printout of required number of formats (scan copy) from
computer.(True/False)
Ans. False
12.
Equipment/Instrument/system and other usage
logbook shall be issued by authorized QA personnel with
certification(TRUE/FALSE)
Ans. TRUE
13.
In process and finished product TDS shall be
enclosed with respective batch manufacturing and packing record(TRUE/FALSE)
Ans. TRUE
14.
Which
deparment shall maintain the issuance record of TDS?
Ans. 1. Quality
Control
2. ARD
3. QC & ARD
4. QA
15.
All
Logbooks shall stamped as “QA” on each page.(True/False)
Ans. False
16.
Pre-printed logbooks shall contain Approval
Table & Page No. in footer. (True/False)
Ans. False
17.
Stability TDS shall be retained in QC/ARD.
(True/False)
Ans. fALSE
18.
If any format not used by any reason in
current month, such format can be used in upcoming month.(True/False)
False
19.
Stability TDS shall be retained in
QC/ARD.(True/False)
fALSE
20.
If any format not used by any reason in
current month, such format can be used in upcoming month.(True/False)
False
21.
Who shall be responsible for tracking of all
master documents for revision as per current revision?
A) Concern
department Head
B) Authorized
QA Personnel
C) Both
of above
D) None
of above
22.
Which department shall retain master Job
Responsibilities of employees?
HR Department
23.
Documents such as SOP, Specification, STP,
Monthly Schedule and GTP shall not be distributed without any request.
(TRUE/FALSE)
False
24.
BMR & BPR shall be distributed as per
SOP of Document & Data Control. (TRUE/FALSE)
TRUE
25.
Documents issued to the customer/vendor for
reference purpose outside the premises shall be stamped as................?
Un controlled copy
26.
Whenever any document revised, who shall be
responsible to return the old version documents to QA?
Concerned Department
27.
Define the tolerance period for revision of
documents except SOP’s?
Within 30 days
28.
Who shall be responsible to prepare the
Document Review Plan?
Authorized QA Personnel
29.
Define the review period of Logbooks?
First week of the month or within 07 working days
30.
Who shall authorized to approve or reject
the document?
Head-QA/Designee
31.
Who shall prepare the Training Need Identification
of employees.........
A) Executive/Designee-HR
B) Concerned Department Head/Designee
C) QA
Personnel
D) Head QA or Designee
32.
GMP training shall be given based upon the
Training Need Identification of new employee (TRUE/FALSE)
FALSE
33.
QA shall be responsible to conduct the
training on Data Integrity and GDP once in six months to ensure the 100%
training of employees (TRUE/FALSE)
FALSE
34.
Who shall make arrangements of external
training?
Head-HR/Designee
35.
Master copy of Job Responsibility shall be
submitted in......................... by concerned department and shall
enclosed in departmental file in HR department.
HR Department
36.
Annual training schedule shall be submitted
to QA in last week of December for next year (TRUE/FALSE)
TRUE
37.
.................of training schedule shall
be submitted to HR department for monitoring and to ensure the training of each
department.
A) Controlled copies
B) Un-Controlled
copies
C) None
of above
38.
Contract/temporary worker should be the part
of training need identification/On Job Training (TRUE/FALSE)
FALSE
39.
The training file of the employee shall be
kept in the QA department (TRUE/FALSE)
FALSE
40.
If any employee leaves the job, his / her
training file shall be submitted to ............. department.
QA
41.
All GMP activities shall be supported by
written procedures (TRUE/FALSE)
TRUE
42.
Data entries shall be recorded in
............... time
Real
43.
Use of shorthand notations is
........................
1) Not allowed
2) Allowed
3) None
of above
44.
The preferred method for recording date
& time uses the format as................?
DD/MM/YYYY
45.
Time shall be recorded in 24 hours clock
format (TRUE/FALSE)
TRUE
46.
Who shall be responsible for Issuance and
logging of change control format?
A) Executive/ Designee- QA
B) Head
of Originating Department
C) Executive/
Designee Originating department
D) Head/
Designee-QA
47.
The changes, which have significant impact
on the formulation, identity, quality, safety, efficacy, purity and established
system and procedure are .............................?
A) Minor
Change
B) Moderate
Change
C) Major Change
48.
Head of origination Department shall select
the other departments by indicating with a tick mark in the applicable box in
change control form (TRUE/FALSE)
FALSE
49.
Need
based scanned copy
of actual change control proposal
can be shared with customer for
their reference, if requested (TRUE/FALSE)
TRUE
50.
In case of rejection of change control
proposal from Customer or Regulatory Agency, change control shall be considered
as.................?
A) REJECTED
B) APPROVED
C) None of Above
51.
The final closure of change control shall be
done after completion of post implementation impact assessment (TRUE/FALSE)
TRUE
52.
All the change proposals shall be approved
or rejected within ............ working days from the date of initiation of the
proposed change control.
A) 30
B) 15
C) 07
D) None
of above
53.
Extended period for closing of Change
Control is of 15 working days for minor, moderate and major Change Control
(TRUE/FALSE)
FALSE
54.
QA shall carry out trend analysis of all
change control on monthly basis (TRUE/FALSE)
FALSE
55.
Change control for new product shall be
initiated by .................. department in case of introduction of new
product on generic basis.
Production
56.
Who shall be responsible to label the hot
point location and locate the temperature monitoring device to hot
point.........................?
A) Executive/Designee-QAD
B) Executive/Designee-ENG
C) Both
of above
57.
Mapping activity shall not be performed by
outside Agency (TRUE/FALSE)
FALSE
58.
Mapping study shall be done in the
....................................of the year or whenever required.
A) Hottest period/month
B) Coldest
Period/month
C) Every
month
D) None
of above
59.
The data logger should have
user-programmable data sampling period,
with time intervals ranging from.............................?
A) 10 Sec to 15 minutes
B) 05
Sec to 10 minutes
C) 10
Sec to 10 minutes
D) 15
Sec to 15 Minutes
60.
Distance between each data logger shall
be........................................?
5-10
meter
61.
Who shall be responsible to investigate the
deviation & carryout root cause analysis?
A) Head/ Designee Originating
Department
B) QA
Personnel
C) Head/Designee-QA
D) None
of above
62.
Deviation can be classified in two
types.................?
1)Planned Deviation 2)
Unplanned Deviation
63.
Deviations which are discovered after it
occurs and are accidental called as ...............?
Unplanned Deviation
64.
Initiator shall also perform the root cause
analysis, to identify the root cause for the deviation (TRUE/FALSE)
TRUE
65.
In case of non-quality impacting deviations
the risk assessment should be performed (TRUE/FALSE)
FALSE
66.
If deviation need to be circulated to
Regulatory authority, Who shall forward the deviation to regulatory authority
through means as applicable.
A) RA
B) QA
C) None
of above
67.
After the approval of deviation by Head QA,
the shall execute the CAPA.
A) Initiating department
B) QA
Department
C) None
of Above
68.
All deviation shall be closed within
.......... working days after approval of the deviation.
30
69.
On rejection of proposed deviation, it shall
be deemed as closed and no implementation or verification shall be performed
(TRUE/FALSE)
TRUE
70.
QA shall carry out trend analysis of all
deviation to assess reoccurrence of deviations (TRUE/FALSE)
71.
Who shall be responsible for preparation of
URS for the respective equipment/Instrument/utility?
Head/Designee-Concerned Department
72.
FAT is performed at supplier site (TRUE/FALSE)
True
73.
A maintenance system designed to detect and
prevent problems before they occur called as......................
Preventive
maintenance
74.
Design Qualification shall be prepared by
the QA Department on the basis of vendor/ Supplier documents and recommendations
(TRUE/FALSE)
FALSE
75.
PQ of equipment shall be done after
successful completion of OQ (TRUE/FALSE)
TRUE
76.
After completion of PQ equipment/instrument
shall be certified as qualified and handover to .................... for
routine use.
User Department
77.
PLC/HMI shall be verifying in every ........
years for their input/output check.
A) 05 Year
B) 01 Year
C) 03 Year
D) None of above
78.
Change control procedure shall not be
followed for re-qualification activities except scheduled qualification
(TRUE/FALSE)
FALSE
79.
What is the re-validation frequency for
Major Equipment’s ....................?
05 Years±30
Days
80.
Qualification & Re-qualification
schedule shall be prepared by Engineering department (TRUE/FALSE)
False
81.
Who shall be responsible to identify the new
vendors?
A) Head/Designee-Purchase
B) Executive/Designee-QAD
C) Head/Designee- QCD/ARD
D) None of above
82.
Audit observations shall be categorized
as................?
1) Critical
2) Major
3) Minor
83.
Vendor shall submit CAPA for audit
observations within ............ working days from receipt of audit report?
A) 30
B) 15
C) 07
D) None of above
84.
Who shall prepare Vendor Audit Schedule?
QAD Personnel
85.
Vendor should revert with filled “Vendor
Questionnaire” within 07 working days (TRUE/FALSE)
FALSE
86.
In case of Active Raw Material, vendor may
be approved /rejected on the basis of the provided
documentation(TRUE/FALSE)
FALSE
87.
The representatives from
.................... shall carry out vendor audit.
A) Purchase Department
B) Quality Assurance
C) Quality Control
D) Production
88.
After Six months’ review ± 7 days, vendor
shall be added in approved vendor list (TRUE/FALSE)
FALSE
89.
Vendor evaluation and rating summary shall
be performed on .................?
A) Yearly basis
B) Monthly Basis
C) Both of above
90.
Approved vendors (Raw & Packing
Material) of Tirupati Group shall not be considered approved in Pontika
Aerotech Limited(TRUE/FALSE)
FALSE
91.
Who shall prepare the Site Master File?
Executive/Designee-
QAD
92.
Who shall Approve the Site Master File?
Head QAD
93.
Who shall provide necessary information and
documents to QA for preparation of site master file?
Head/Designee
of Concerned Departments
94.
The numbering system of site master file
shall be…………….
PAL/SMF/RR
95.
What are the references of this SOP?
PIC/S- PE008-4
96.
.................................shall be
responsible for Affixing the label as per defined procedure?
A) QA Department
B) HR Department
C) Concerned Department
97.
Who shall be ensure the issuance of labels?
Executive/Designee
QAD
98.
Status labeling is defined as identification
of the materials, equipments, containers, instruments for the intended purpose
and present status? (TRUE/FALSE)
TRUE
99.
…………………… label shall confirm to status of
Material/Product/Equipment/Area?
Status
100. Which
Department shall indent for the label & maintain inventory and handling of
label?
User
department
Read Part 2 Here