Tuesday, 5 January 2021

Top 100 Quality assurance Interview Questions in Pharma Industry

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 2

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B)              Superseded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

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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