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Head of Quality Control (external)

Head of Quality Control on an interim or part-time basis: duties under § 12 AMWHV

Under § 12 and § 14 AMWHV, the Head of Quality Control is responsible for testing starting materials and finished products and confirms in the test record that the product has the required quality. If the post is vacant or still to be established, A&O Pharma fills it on an interim or part-time basis at your site, integrated into your quality management system.

Arrange an initial consultation How we work with you

§ 12

AMWHV sets out the duties of the head

§ 14(4)

AMWHV: signature on the test record

People in our team holding this position

Key points at a glance

Legal basis checked against the statutory text, as of October 2026

Manufacturers holding an authorisation under § 13 AMG appoint a Head of Quality Control as key personnel, independent from Production, as required by Chapter 2.5 of Part I of the EU GMP Guide.
The Head of Quality Control approves or rejects starting materials, approves specifications and test instructions, monitors contract laboratories and confirms every test with date and signature.
A&O Pharma provides an experienced person on an interim or part-time basis who works at your site, is integrated into your quality management system and appears in your job descriptions and organisation chart.

On site

Who is responsible for what.

Production and quality control work independently of each other and each sign their own record. Only on this basis does the Qualified Person release the batch.

Head of Production § 13 AMWHV Batch manufacturing record

This role Head of Quality Control § 14 AMWHV Test record

Qualified Person § 14 AMG, § 16 AMWHV Batch release

Simplified, based on Sections 12 to 16 AMWHV

At A&O Pharma

How we work with you.

Until the post is filled

Bridging a vacancy or absence

Your Head of Quality Control is leaving, on long-term sick leave or on parental leave. We take on the role until the post is filled again, so that test records continue to be signed properly.

New authorisation, new laboratory

Setting up quality control

You are applying for a manufacturing authorisation or establishing a new site. We take on the role during the set-up phase, draw up specifications and test instructions with you and support the validation of test methods until your own team is in place.

Scaled to need, with justification

Part-time for smaller operations

Where testing volumes are small or you rely mainly on contract laboratories, the role does not fill a full position. The EU GMP Guide states that key posts should normally be occupied by full-time personnel (Chapter 2.5). Your authority decides whether a part-time arrangement is sufficient; we prepare the justification with you.

Process

How we get started.

Initial conversation

You tell us about your site, your products, your laboratory and the reason for your enquiry. We reply within 1 to 2 days and tell you plainly whether, and to what extent, we can take on the role.
Contract, job description and organisation chart

The duties are laid down in writing, as § 12(1) AMWHV requires. The job description and organisation chart are updated in line with § 4(2) AMWHV and approved under your internal procedures.
Integration into your operations

The person works to your SOPs, is introduced to your laboratory and processes and is clearly separated from the Head of Production. § 20 AMG requires notification of changes to the particulars listed in § 14(1) AMG, such as the Qualified Person; the Head of Quality Control is no longer named there. We agree with you how your authority is to be involved.
Start and handover

After the induction period the person takes on responsibility, including signing the test record. When the assignment ends, we hand over to your new head in a documented manner.

Arrange an initial consultation

What the law requires

Who needs a Head of Quality Control

Under Chapter 2.5 of Part I of the EU GMP Guide, senior management appoints key personnel, including the head of Production and the head of Quality Control. Chapter 6.1 states that each holder of a manufacturing authorisation should have a Quality Control Department that is independent from other departments and under the authority of a person with appropriate qualifications and experience. In Germany, § 2 No. 8 AMWHV defines the term and § 12(1) AMWHV sets out the duties. According to Chapter 2.5, key posts should normally be occupied by full-time personnel.

Duties under § 12 AMWHV

The duties must be laid down in writing or electronically. They include in particular:

approving or rejecting starting materials, packaging materials and intermediate products
approving specifications, sampling instructions and test instructions under § 14(1) AMWHV and ensuring that they are followed
ensuring that all necessary tests have been carried out
approving and monitoring contract analytical laboratories
overseeing the maintenance, premises and equipment used for testing
ensuring that the necessary validations of test methods are carried out
ensuring the initial and continuing training of testing personnel

Starting materials and finished products are tested under the responsibility of the Head of Quality Control (§ 14(1) AMWHV). The Head of Quality Control confirms with date and signature in the test record that the testing was carried out in accordance with the test instructions and that the product has the required quality (§ 14(4) AMWHV). Release is not permitted unless the test record has been properly signed (§ 16(2) No. 1 AMWHV).

Independence and relationship to the Qualified Person

The heads of Quality Control and Production must be independent from each other (§ 12(1) AMWHV, EU GMP Guide Chapter 2.5). Chapter 6 describes the independence of Quality Control from Production as fundamental. The same person therefore cannot hold both roles. The Head of Quality Control may, however, also be the Qualified Person: Chapter 2.5 requires a separate Qualified Person only where the heads do not themselves carry out the duties under Article 51 of Directive 2001/83/EC. Releasing each batch remains the task of the Qualified Person under § 14 AMG (§ 16(1) AMWHV).

Qualification

Unlike the Qualified Person under § 15 AMG, § 4 and § 12 AMWHV do not prescribe a specific degree for the Head of Quality Control. § 4(1) AMWHV requires competent and adequately qualified personnel who are deployed only in line with their training and knowledge. Chapter 2.1 of the EU GMP Guide calls for the necessary qualifications and practical experience, and Chapter 6.1 for a head with appropriate qualifications and experience.

Organisation at your site

For staff in managerial or responsible positions, § 4(2) AMWHV requires:

job descriptions setting out their duties
an organisation chart showing the reporting lines
no gaps or unexplained overlaps between areas of responsibility
sufficient authority to carry out their responsibilities

Under Chapter 2.3 of the EU GMP Guide, duties may be delegated to designated deputies of a satisfactory qualification level.

Named individually

Who holds this role at A&O.

You know who is responsible for you before the contract starts and can reach that person directly. Cover comes from the same team.

Dr. Kai Huwig Qualified Person (QP) under § 14 AMG Qualified Person (QP) and Head of Quality Control

Case studies

How we have solved this before.

All cases

Mid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur

Qualified Person (QP) and Head of Production provided

A marketing authorisation holder needed a Qualified Person (QP) for batch release and, at times, a Head of Production. We provided both, and business operations continued...

Read case

Weighing it up

External via A&O or hire your own?

	External via A&O Pharma	Hire your own person
Start	No recruitment process; starts once contract and induction are in place	Advertising, selection and notice periods determine the start
Scope	Interim or part-time; your authority decides whether part-time is sufficient	Normally full-time, as Chapter 2.5 of the EU GMP Guide provides
Knowledge of your site	Induction into products, laboratory, test methods and SOPs is required	Builds up over time and stays in-house
Integration	Included in job descriptions, organisation chart and quality system like your own head	Part of your organisation from the outset
Duration	Bridging or set-up, with a planned handover to your own head	Permanent solution

Frequently asked questions

What we are often asked.

What does the Head of Quality Control do?

The Head of Quality Control approves or rejects starting materials, packaging materials and intermediate products, approves specifications, sampling and test instructions, ensures that all necessary tests are carried out and monitors contract laboratories (§ 12(1) AMWHV). In the test record, the Head of Quality Control confirms with date and signature that the product has the required quality (§ 14(4) AMWHV).

Can the Head of Quality Control also be the Qualified Person?

Yes. Chapter 2.5 of the EU GMP Guide requires a separate Qualified Person only where the heads do not themselves carry out the duties under Article 51 of Directive 2001/83/EC. The same person may not, however, also head Production, because the two heads must be independent from each other (§ 12(1) AMWHV).

What qualifications does a Head of Quality Control need?

§ 4 and § 12 AMWHV do not prescribe a specific degree. They require competent and adequately qualified personnel (§ 4(1) AMWHV), and Chapter 6.1 of the EU GMP Guide refers to a person with appropriate qualifications and experience. Your authority assesses whether the qualification is adequate for your products. If the same person is also to act as Qualified Person, the requirements of § 15 AMG apply in addition.

Is the Head of Quality Control still regulated in the AMG?

Not expressly. § 14(1) No. 2 AMG, which used to name the Head of Quality Control, has been repealed. § 2 No. 8 AMWHV still refers to that provision, but the duties are now set out in § 12 AMWHV and in Chapters 2 and 6 of the EU GMP Guide.

Can testing be outsourced to an external laboratory?

Yes. § 14(4) No. 3 AMG allows testing in contracted establishments, provided suitable premises and facilities are available there and the Qualified Person can exercise their responsibility. The Head of Quality Control must approve the contract and monitors the contract laboratory (§ 12(1) AMWHV). Chapter 6.6 of the EU GMP Guide requires this to be stated in the Quality Control records.

Can the Head of Quality Control post be filled part-time or by an outside provider?

The EU GMP Guide states that key posts should normally be occupied by full-time personnel (Chapter 2.5). Your authority decides in each case whether a part-time arrangement is sufficient. What matters is that the person is integrated into your operations and quality system, appears in the job description and organisation chart and has sufficient authority (§ 4(2) AMWHV). That is how we work.

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