Quality Assurance Officer

Job Title: QUALITY ASSURANCE OFFICER

Department: QUALITY REGULATORY AFFAIRS DEPARTMENT

Location of Post: North Industrial Area Site/Tesano

Responsible For: Responsible for online In-Process Quality Assurance & Control (IPQA & C) during products manufacture.

MAIN PURPOSE AND SCOPE OF THE JOB

1)     Responsible for the online real-time inspection and monitoring of compliance to manufacturing quality assurance procedures and in-process quality checks of intermediate products running at the workstation to ensure consistent final product compliance to specification and marketing authorisation.

2)     Responsible for ensuring compliance to cGMP and QMS guidelines of the company in all relevant business operations and across the production floors to ensure quality is built into the company’s products and services.  

3)     Responsible for the inspection and assurance of compliant production process documentation and BMR entries to ensure input materials traceability.

4)     Responsible for line clearance as per BMR guidelines before and after every batch production

5)     Responsible for performing any other quality assurance activities assigned by the quality manager.

GENERAL IPQA/C RESPONSIBILITIES

1.      Responsible for ensuring prompting and supervising workstation line clearance operations (as per BMR guidelines) before and after the manufacture of every batch or the close of a shift or start of a shift operations at the workstations to avoid mix-ups and cross-contaminations.

2.      Responsible for observing and verification of all production input materials dispensing activities at the production floor.

3.      Responsible for ensuring and verifying the appropriate status labelling of the workstations before and throughout manufacturing at the workstation to provide real-time workstation status information as required in cGMP.

4.      Responsible for holding the production line or any QMS related operation in events of non-compliance and reporting same to quality assurance supervisors and production supervisors or the relevant operational supervisors for remedial actions as per the appropriate SOP before resumption of operations.

5.      Responsible for verifying that the approved product specification reference documents and reference samples (packaging materials) are at the workstation before the start and throughout the batch production.

6.      Responsible for verifying that the appropriate BMR corresponding to the product description or specification is deployed at the workstation before batch production starts and are being filled with real-time information right there on the line.

7.      Responsible for ensuring real-time and controlled documentation of manufacturing activities including continuous verification of data being fed into BMR to ensure that the BMR (is a true representation of manufacturing activities during of the manufacture of the product stated in the BMR) represent the undisputable record of events and observations in the course of manufacturing of the product

8.      Responsible for verifying and ensuring that all the input materials assembled at the workstation or brought to the workstation during production are the required materials matching the specifications stated in the BMR and all carry QA release numbers and QC Passed/Released Labels. 

9.      Responsible for ensuring production officers do not introduce any defective input material/s(OOS, NC material, untested, expired, quarantined, rejected material, under-investigation/test material) into any product at any point along the manufacturing process chain.

10.  Responsible for ensuring and verifying that every input material used at a workstation for manufacturing is recorded in the product’s BMR with item Batch number, QA release number, Expiry and Manufacturing date and with observed specifications recorded against the prescribed specification in the BMR or job materials specification, otherwise raise objection and non-compliance.

11.  Responsible for reporting every non-compliance at the workstation to the supervisors( QA and Production) and quality manager when your corrective instruction is over-ruled or ignored by operators, officers or managers at the workstation.

12.  Responsible as online quality controller to operators by alerting them to stop for system/setting corrections, adjustment or restoration when you observe a defect, observe a defect is about to happen or receive a QC report of defective online production during laboratory IPQC checks.

13.  Responsible for helping ensure No final product is defective by providing real-time guidance to production through scheduled regular in-process testing (IPQC) to ensure that intermediate products are continuously within approved specification.

14.  Responsible for raising and issuing a non-compliance report to production manager in charge and the master copy filed at QA/QC department when;

1)     A material without QA/QC Released or Passed label on it is being used at the workstation

2)     An expired material is being used at the workstation

3)     A material or materials being used at the workstation differ in specifications from what is provided in the BMR or Job reference materials specification

4)      Production is being carried out without the customer’s approved reference artwork at the workstation

5)     Production is being carried out without the approved Master Job specification at the workstation

6)     Operator ignores an instruction to halt for correction but proceed to produce defective product against specification

7)     The approved process time or duration for a unit process or stage of production is violated outside the tolerance range.

15.  Responsible for raising and issuing an incidence report to the production manager in charge with the master copy filed at QA/QC department when an unexpected event occurs on the production line/workstation, which may have direct or indirect impact on product quality and safety or production volume output such as;

1)        Observed product defect or OOS was flagged but was immediately corrected by operator

2)        A material without QA/QC released label found its way to the workstation but has been flagged and taken away

3)        Halt in production due to poor quality of products or poor quality of input material/s

4)        An expired or wrong material found its way to the workstation but has been flagged and taken away

5)  Change in ink mixing ratios or in chemicals instead of the original documented procedure just so the get product within specification.

6)        Faulty machine working with high defect rate or total machine breakdown/failure and repairs

7)        Power outage

8)        Stifling high room temperature at the workstation

9)        Injury to a worker on the job

16.  Responsible for ensuring that documented operations are properly signed by operators executing them in real time by themselves, are verified, and countersigned in the BMR by you the online inspectors on duty at the workstation in the place of the quality manager: This is required for operators’ responsibility and risk control in food defence program.

17.  Responsible for writing IPQC online checks SOPs for manufacturing operations and activities on the production floor.

18.  Responsible for helping provide IPQC support to production at all materials times to avoid final products defect and ensure traceability of input materials in the production space.

19.  Responsible for online sampling according to the online inspections plan/schedule and handing over to QC analysts for laboratory checks and advice.

20.  Responsible for transmitting the results of IPQC laboratory checks on online samples to the machine operators at the workstations for guidance.

21.  Responsible for recording online inspection observations and the results of IPQC laboratory checks on online samples in the IPQC online inspections log/sheet for every product.

PERSON SPECIFICATION

SKILLS AND ABILITIES

Technical

·  Very meticulous and attentive to details

·  Ability to interpret and execute technical operational SOPs with minimum supervision to obtain consistently good results.

·  Ability to investigate product failures and product defect complaints and generate appropriate CAPA

·  Ability to write and review technical and operational quality control standard operating procedures.

·  Good verbal and written scientific communication skills

·  Ability to process raw data for trend analysis and graphical presentations

·  Ability to write weekly, monthly quality and annual evaluation reports.

·       Excellent in verbal and written communication.

EXPERIENCE

·      2 years QC/QA laboratory exposure in cGMP or higher QMS environment.

QUALIFICATION & KNOWLEDGE

·      Bachelor of Science (BSc.) Chemistry/ Physics, Materials Science/ Laboratory Science or Diploma in Science Laboratory Technology

PERSONAL ATTRIBUTES AND

OTHER

REQUIREMENTS

·      Strict, firm and fair in dealing with other people

·      Honesty with high integrity

·      Diligent with High sense of urgency and responsibility

·      Proactive and Innovative with initiates drive and result-oriented

·      Good team player and problem solving skills.

·      High capability of critical analysis/thinking, meticulous and detail-oriented/attentive to details.

To apply for this role, please send your CV and Cover Letter via email to dasrecruitments@dasplcgh.com.

Application deadline is Tuesday, 28th July, 2026.  

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