Operations Supervisor

The Operations Supervisor is

responsible for ensuring operational activities are carried out in

compliance with GMP regulations, hygiene rules, and safety

standards. They must ensure adherence to the established production

plan while following procedures defined by the pharmaceutical

site’s quality system. They will also be

responsible for supervising operators and technicians during

operational steps. The Operations Supervisor manages and plans GMP

cleaning of production areas.

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Throughout the site construction project

phase, the Project Team operates at a rapid pace, managing

large-scale and intricate construction and engineering tasks. In

this start-up-like environment, the pace is fast, and changes are

constant. Adaptability, proactivity, and a willingness to embrace

uncertainties are essential. The successful incumbent will thrive

on taking initiative, excel at wearing multiple hats, and can

switch roles swiftly as circumstances evolve. Collaboration is

critical in this dynamic setting, with open communication and a

team-first attitude driving success.

Serve as the

focal point for supporting the Project Team members in relation to

operational activities by demonstrating a proactive approach and

the ability to anticipate

needs.

Coordinate and

orchestrate site visits for process equipment vendors for the

installation and qualification

activities.

Assists in

the execution of process equipment testing and startup activities,

along with developing necessary operational

procedures.

Collaborate

with internal and external stakeholders to initiate and manage 3rd

party services for GMP

areas.

Communicate

with external partners, contractors, government departments, and

other stakeholders on a variety of different documents and

agreements as

required.

Act as a

dedicated member of the Project Team, supporting project execution

and taking on responsibilities as assigned by the Site

Head.

After

the site is operationalized, the position will lead the Site

Support Team to ensure smooth site administrative operations in

collaboration with internal and external

parties.

Operations

& Team

Management

Plan

work and supply

needs.

Communicate and

explain work

instructions.

Train or

ensure training of staff on procedures (as the Job Qualified

Trainer).

Assign

workstations, lead, and coordinate team

activities.

Troubleshoot

technical issues and make necessary adjustments (with support

services if

needed).

Operate

production lines when permanent operators are

absent.

Maintain team

cohesion and

motivation.

Propose

and implement improvements in work

organization.

Review

production packaging records before Quality Assurance

review.

Serve as the

main contact point during audits in the

area.

Compliance

Documentation

Ensure

execution of industrial batch packaging operations in GMP

environments while meeting the established

schedule.

Ensure

compliance with hygiene, environmental, and safety (EHS) rules and

guidelines.

Check,

record, and complete pre-established work documents to ensure

traceability of performed operations (batch records completed per

GMP standards).

Draft

technical documents necessary for equipment operation (user and

cleaning instructions, etc.) and other documentation required for

packaging

operations.

Open

deviations in the quality IT system and ensure timely

closure.

Perform and

follow up on CAPA actions in the quality IT

system.

Equipment

& Process

Management

Manage

the company responsible for GMP cleaning of production areas and

establish cleaning schedules in collaboration with them, according

to production

constraints.

Participate

in the qualification / validation of packaging production

equipment.

Maintain

packaging line indicators and communicate them to the

team.

Collaborate with

EHS to assess risks and perform risk

analyses.

Promote

continuous improvement within the

team.

Safety

& Risk

Management

Maintain

a healthy and safe working environment in controlled areas and

ensure compliance with applicable laws and

rules.

Ensure staff

(including temporary and short-term contracts) are properly

informed of risks and trained to act

accordingly.

Promote

safe behaviors and practices, verify EHS rules are implemented and

followed.

Immediately

report all incidents and near misses to the EHS department,

participate in investigations, and identify preventive measures to

avoid

recurrence.

Preferred

Qualifications : Strong

knowledge of GMP environment and solid understanding of the

pharmaceutical industry, especially in blending, encapsulation,

powder compression, and other oral dosage manufacturing

processes.

Versatile,

organized, rigorous, and an effective communicator with excellent

interpersonal skills for

teamwork.

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Experience /

Education

minimum of a bachelor‘s or associate degree with over 6 years of

experience in manufacturing site

operations.

Working

knowledge of manufacturing and R&D

operations.

Proven

experience in leading and managing a

team.

Proficiency in

handling local codes and regulations while maintaining

international

standards.

Highly

self-motivated individual capable of working with minimum

guidance.

Languages : English

Knowledge

/ Skills /

Abilities : Strong

knowledge of GMP environment and solid understanding of the

pharmaceutical industry, especially in blending, encapsulation,

powder compression, and other oral dosage manufacturing

processes.

Versatile,

organized, rigorous, and an effective communicator with excellent

interpersonal skills for

teamwork.

Natural

leadership, able to share expertise, technical knowledge, and

experience to develop the

team.

Strong

management

skills.

Proficient in

basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to

use them for presentations and

reporting.

Proactive

in proposing and implementing work organization

improvements.

Strong

problem-solving

skills.

Able to

communicate activity progress and issues

encountered.

Capable

of leading continuous improvement projects with support

departments.

Strong

sense of

responsibility.

Ability

to manage

projects.

Comfortable

giving presentations to

groups.

Knowledge of

various packaging processes in dry

formulation.

Willing

to share knowledge and train new employees and operators on

packaging

equipment.

An

Equal Opportunity Employer. All qualified applicants will receive

consideration for employment without regard to race, color,

religion, sex, sexual orientation, gender identity, national

origin, or protected veteran status and will not be discriminated

against on the basis of

disability

This

job description does not state or imply that the above are the only

duties and responsibilities assigned to this position.

Employees holding this position will be required to perform any

other job-related duties as requested by

Management.