Bioniche Pharma
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CAREERS

Cleanroom Supervisor
Date: Feburary 1, 2012
Reporting To: Production Manager
Department: Production
Location: Inverin, Co. Galway, Ireland

ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

  1. Supervising all filling/ jet printing activities and ensure that all activities are performed to GMP standard.
  2. Review manufacturing documentation after batch completion and follow up with relevant personnel to ensure that documentation is complete. Complete all batch related report e.g. deviation and incident reports as required by quality.
  3. Responsible to ensure annual reviews are completed with relevant staff.
  4. Ensure that classified areas and its environs are kept to the highest standards of cleanliness.
  5. Ensure all training activities are completed within allocated timelines.
  6. Perform other duties as assigned.

QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE
Must possess knowledge of manufacturing processes within a pharmaceutical/ medical device environment (previous supervisory experience within a pharmaceutical company would be a distinct advantage) .

Must possess previous experience of working to GMP regulations as well as gowning experience for a Grade A/B environment or equivalent.

SKILLS AND ABILITIES
Must possess the following skills;
  1. Excellent communication and interpersonal skills.
  2. Be able to consider all the facts and make good sound decisions.
SUPERVISION
Position functions autonomously. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE
Minimum of a Diploma (or equivalent) in a life science and 2-3 years of experience in a manufacturing environment (preferably pharmaceutical). Previous experience in similar supervisory role would be a distinct advantage.
However, a combination of experience and/or education will be taken into consideration.


LICENSES/CERTIFICATIONS
None required.

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply and divide.

REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms to lift and scoop. May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically pushing, rolling or lifting. May be required to wear personal protective equipment including but not limited to: respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing. Heavy lifting requirements in Grade D environment.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Normal office, cleanroom & manufacturing environments.

TO APPLY
All applications should be forwarded to careers@bionichepharma.com