Quality Assurance Executive (Pharmaceutical Manufacturing)

Report to Quality Assurance Manager, This job description gives a general outline of the duties of the post and is not intended to be an inflexible or finite list. It may therefore be varied so that changing needs of the service can be met, in consultation with the post holder.

Role Responsibilities

Batch release

1. Review batch documentation and verify records are in compliance with GMP, validation records and relevant associated documentation to release the product for use

2. To inspect the finished product for compliance to relevant specifications

3. To review all relevant in process tests results and QC data relating to the batch

4. To document the batch release process in compliance with GMP

5. To escalate any rejected batches to senior management

Documentation

1. To comply with the organisation’s Documentation Policy.

2. To generate and maintain documentation ensuring contemporaneously completion and in a clear written language.

3. To maintain the documentation control system in accordance with cGMP and company SOP

4. Generate, review and approve batch manufacturing records (Worksheets, etc).

5. Generate and maintenance of technical documents i.e. master batch documentation, validation documentations, specification documents, standard operating procedure and technical agreements.

Quality Management System

1. Work with the quality management system to ensure compliance to regulations.

2. Coordinate, write and review quality exception reports, corrective and preventive actions (CAPA), change controls, customer complaints and quality investigations.

3. Facilitate timely follow up and closure of deviations, change controls and corrective and preventive actions (CAPA).

4. Write and review quality reports.

5. Tracking of documents and validation activities.

6. Ensure compliance to cGMP standards and provide support to the quality management operations.

7. Review of site environmental monitoring programs.

8. Monitor and maintain all quality system process to identify improvement opportunities.

Training

1. To draft and execute training materials for all BOVA UK staff members.

2. To maintain all training records and review training files on periodic basis.

3. Perform periodic peer observations of various team members for critical process steps and report your observations to department managers.

4. To participate in training programs for quality assurance staff., 14. Respond to correspondence (phone, email, mail or other) in a timely and efficient manner;

5. Other reasonable duties as assigned by senior management on an ad hoc basis.

Job Types: Full-time, Permanent

Benefits:

• Company events

• Company pension

• Cycle to work scheme

• Private medical insurance

• Referral programme

Schedule:

• Monday to Friday

Ability to commute/relocate:

• London: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Do you have experience in reviewing batch documentation and verify records are in compliance with GMP, validation records and relevant associated documentation to release the product for use?

Qualifications: Educated to science bachelor’s degree level or equivalent knowledge/expertise in the field.

Experience: 2-3 years within a relevant Sr.QA Officer role., 1. Minimum education to a degree or NVQ 3 level in Science related discipline or equivalent;

1. Demonstrate an ability to read and interpret documents which relate to health & safety and regulations, operating and maintenance instructions, and procedure manuals;

2. Demonstrate an ability to calculate basic and advanced figures which may include, but are not limited to, discounts, solutions strengths, concentrations, proportions, percentages, weights and volumes;

3. Must demonstrate an understanding of the importance of time management, following instructions and organisational skills;

4. Must possess exemplary computer skills and knowledge and be able to adapt to and learn any new computer software that may need be implemented;

5. Have an ability to follow complex, multistep procedures and processes

6. Must be able to execute the physical demands required for this role including manual handling of equipment and materials;

7. Must demonstrate a willingness to work with chemicals in knowledge of potential side effects, and must ensure that all staff follow the procedures to ensure safe handling of hazardous chemicals;

8. Must demonstrate an ability to conduct complex procedures in an environment in which the noise level may be moderate, and be accurate and prompt;

9. Must demonstrate an ability to perform repetitive work within a busy manufacturing environment

10. Must have professional telephone etiquette skills for communicating with customers and suppliers

11. Must demonstrate excellent communication skills with other staff, suppliers and customers

12. Must be able to work on a multi-departmental level within the organisation to accomplish the overall business goals, Bachelor’s (required), Quality assurance in a pharmaceutical environment: 3 years (required)

• handling QMS documents (change control, Deviation, CAPA etc): 3 years (required)

• in vendor qualification and customer complaints: 3 years (required)

Bova Specials UK Limited

7 Gorst Road, London

Permanent, Full-time