Quality Assurance Executive in Pharma job description
A quality assurance executive in pharma checks that manufacturing, packing and records follow approved procedures, reviews batch documents and supports audits at a drug manufacturing site.
Why the role exists
The role exists because someone independent of production must confirm that each batch was made correctly before it is released. In an Indian plant the executive reports to the QA manager, spends part of the day on the shop floor and part reviewing records and deviations.
What the person does
- Carry out in-process checks on the shop floor, such as line clearance, weight, hardness and fill checks, and record the findings.
- Review completed batch manufacturing and packing records for accuracy and completeness before the QA head signs for release.
- Issue controlled documents such as batch records, logbooks and procedures and keep the issuance register up to date.
- Log deviations, change controls and complaints in the quality system and follow them to closure with the owners.
- Walk through production and warehouse areas to check hygiene, gowning and adherence to procedures, and note observations.
- Draw samples of materials and finished goods as per the sampling plan and hand them to the QC laboratory.
- Help prepare the site for customer and authority audits by checking records, and track audit observations until they are closed.
- Take part in internal audits, vendor qualification and training sessions for plant staff.
Skills and tools
- Working knowledge of good manufacturing practice as applied in a pharma plant
- Reviewing batch records and finding errors, gaps and late entries
- Writing clear deviation and change control reports with facts and impact
- Using a document management or quality management system
- Understanding of line clearance, sampling and in-process checks
- Knowledge of data integrity and good documentation practice
- Courage to stop a batch step or hold material when something is wrong
- Communication that is firm but fair with production and engineering colleagues
Education and experience
Preferred, never a bar: equivalent experience counts.
- B.Pharm, M.Pharm or B.Sc in a science subject preferred, or equivalent experience in pharma quality
- Experience in QA at a manufacturing plant is preferred, ideally one that has faced customer or authority audits
- Training in internal auditing or good manufacturing practice is useful
- Any certification or training expected for the role depends on the employer; confirm with your own adviser
How the work is judged
- Quality of batch record review, measured by errors found before release rather than after
- Timeliness and quality of deviation and change control closure
- Coverage and accuracy of in-process checks across shifts
- Readiness of records and areas for audits, and prompt closure of audit observations
- Working relationship with production, balanced between independence and support
Where the role can lead
- Senior QA executive or officer responsible for a section such as documentation or validation
- Assistant manager QA, handling audits, vendor approval and the quality system
- Move into regulatory affairs or quality systems with further experience
Interview questions to ask
Ask every candidate the same questions in the same order and score them against written anchors, so the decision rests on the work and not the impression.
- You find a missing signature on a batch record that is ready for release. What do you do and who do you tell?
- Production asks you to approve line clearance quickly because dispatch is waiting. How do you respond?
- Describe a deviation you investigated. How did you establish the root cause and what action followed?
- How do you check a batch record so that errors do not slip through when you have many to review?
- What would you do if you noticed an operator working in the clean area with incomplete gowning?
- How do you prepare a block for a customer audit in a short time?
Hiring tips for this role
- Give a sample batch record with planted errors and ask the candidate to review it. This shows attention to detail better than any question.
- Probe independence. QA staff who are afraid to say no to production are a risk to the plant.
- Distinguish QA from QC in the interview; some candidates have only laboratory experience and do not know record review.
- Ask what audits the candidate faced, what the observations were and how they responded, and cross-check with a past manager.
Questions about hiring a quality assurance executive in pharma
QC tests samples in the laboratory. QA looks at the whole system: procedures, records, deviations and release decisions. The two work together but report separately, and the job descriptions should make that difference clear.
Yes, in most plants. In-process checks, line clearance and area walk-throughs are done on the floor, and record review happens at the desk. The balance depends on the plant and the shifts.
Pharmacy and science graduates are common. Whether any certification or registration applies depends on the employer, the state and the facts, so confirm it with your own adviser before advertising.
GullyHR agrees the job description with you, finds and screens candidates for your site and supports the offer. We hire for your permanent team and do not supply contract staff.
Hiring a quality assurance executive in pharma?
GullyHR runs talent acquisition for permanent roles. We agree the job description with you, find and screen candidates against it, and support the offer through to joining. We recruit permanent employees. We do not supply contract or temporary staff.