Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 44 hours ago

Quality Assurance Operations Department

Interdot Solutions352 open roles

Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowQuality Assurance Operations DepartmentInterdot Solutions

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Interdot Solutions's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

11.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: first seen 44 hours ago

The posting

Quality Assurance Operations Department

QUALIFICATIONS NEEDED:

Bachelors degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent. NECESSARY

EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 8 years experience in the vaccine/ biotech/ sterile or pharmaceutical manufacturing industry.
  • At least 3 years experience at middle to senior management level in cGMP pharmaceutical manufacturing or equivalent
  • Experience in quality and regulatory compliance within a cGMP facility.
  • Strong knowledge of sterile manufacturing environments.
  • Experience in having faced successful local and international quality audits.
  • Experience in business operational planning and participation in developing the departmental budget.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Full responsibility for all areas within Quality Assurance Operations sections consisting of Operations, Systems, Training, and Compliance.
  • Overall management and implementation of specified QA processes and document systems including Deviations, CAPAs, Change Controls, National Regulatory Audits Quality Risk Management, and Track wise Management.
  • Review and approve documentation within defined timelines as stated in SOP.
  • Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of the contract the manufacturers, contract laboratories, etc.
  • Ensure that significant changes to the facilities, equipment, and processes, which may affect the quality of products, are validated.
  • Ensure that appropriate manufacturing controls are in place, including master manufacturing and packaging documents.
  • Evaluate and authorize any re-processing of products or materials.
  • Ensure that products are released by buying authorization following full batch and testing record review.
  • Ensure that a risk management program and principles are maintained by ICHQ9
  • Participate in the review of the effectiveness of the medicines recall procedure together with the Head of Quality and Responsible Pharmacist.
  • Review and approve out-of-specification investigations, out-of-trend investigations, protocols, and reports within defined timelines as stated in SOP.
  • Review, approval and sign off all operational documents and records, e.g., System and Component Impact Assessments, GMP reviews, Design qualification, Risk Assessment, IQ, OQ, PQ, periodic re-qualification, Performance testing, Aseptic Process Validation, Process validation, Analytical Methods Validation, Cold-chain Packaging validation, and Cleaning Validation documents.
  • including both Protocols and Reports to ensure compliance with site approaches, cGMP, and regulatory agency requirements.
  • Benchmark against quality standards of the industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site.
  • Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Company and auditors.
  • As appropriate, write / review / approve/reject and/or control GMP Documentation and Records to ensure compliance with the requirements of the business, cGMP, and Regulatory agencies.
  • Ensure timeous response to customer and regulatory inspections and audit reports.
  • Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems
  • Ensuring that the document control activities are achieved at the required quality levels (Companys, SAHPRA, and WHO), within the agreed timeframe and ensuring proper management of archived documents.
  • Maintain Sterility Assurance aspects on-site including investigations and improvements.
  • Ensure that Sterility assurance complies with cGMP and is continuously improved on-site.
  • Defines, implements, and owns the site's holistic contamination control strategy.
  • Evaluates, improves and owns the site's holistic environmental monitoring program (including utility monitoring).
  • Leads, participate, and ensures that all QA engagement/interactions with external third-party stakeholders are timeously held and escalate discussion with the Senior Management team.
  • Reviews Critical deviations, Investigations, CAPAs, and Risk assessments
  • Leads and facilitates all audits on-site inclusive of External Regulatory, third-party customers, new third-party partners, etc.
  • Participate and provide quality oversight within defined projects and delegate project deliverables to staff in sections where appropriate according to skill or development.
  • Continuous development and mentorship of the Quality Assurance team
From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Interdot Solutions's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Interdot Solutions's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Interdot Solutions's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.