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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Title:
Manufacturing Technician Level 1
Department:
Manufacturing
Division/Business Function:
Operations
Accountable to:
Team Leader
Accountable for:
N/A
Main purpose of role:
Working under limited supervision to manufacture commercial and clinical pharmaceutical products, to cGMP standards and procedures.
The Manufacturing Technician role is inclusive of the GMP Batch Review function, subject to training level.
Main responsibilities:
- General Responsibilities
- To comply with company policies including internal and external Health and Safety and Environmental standards as required.
- To work in a safe manner with due regard to one’s own safety and that of others. At all times abide with the companies’ health and safety policies.
- Follow the required gowning procedures for all manufacturing areas.
- To wear and maintain the required safety equipment when necessary, as provided by the company.
- To set up the area in preparation for operations in accordance with GMP, including routine checking and testing of equipment and environmental conditions.
- To manufacture solid’s, liquids & semi-solids by using a full range of equipment.
- To inspect tablets, capsules and other pharmaceutical products for defects.
- To complete all documentation promptly and accurately to meet the requirements of documentary evidence for the manufacture of pharmaceutical products (cGMP). Including materials received, reconciliation and when required, to carry out in-process checks, AQL’s and any required integrity testing.
- To clean all areas of manufacturing and associated equipment in accordance with procedure.
- To maintain housekeeping during all manufacturing procedures.
- Complete effective line clearance including the completion of required documentation.
- To calibrate associated equipment as per written procedures and to record results.
- To carry out other reasonable duties as requested by the department Team Leader(s).
- Training Level Specific Responsibilities
- Technician Level 1
- Entry level, no or limited experience, basic understanding
- Works supervised
- Has been placed on a training pathway and has active training ongoing
- Can complete batch records, logbooks and cleaning tags
- Any deviation from this structure is to be approved by Operations Director or General Manager.
- A Technician may only be eligible to move up a level if their attitudes, behaviours and absenteeism meets expected standards and will be reviewed on a case-by-case basis.
- The above is subject to regular review and potentially changes as required.
Regulatory/Industry Responsibilities:
General
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
GMP Requirements Hierarchy
- GMP Skill Level 1 is essential for this role
(further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
General Information:
- Any deviation from this structure is to be approved by Operations Director or General Manager
- A Technician may only be eligible to move up a level if their attitudes, behaviours and absenteeism meets expected standards and will be reviewed on a case-by-case basis
- The company reserves the right to demote a technician should they no longer exhibit the correct behaviours and attitudes that are required in the role.
- A technician is responsible for ensuring the skills are maintained to a high standard
- The above is subject to regular review and potentially changes as required
Qualifications:
Qualifications, Skills and Experience
- Minimum of 4 GCSE’s of grade C or above in Maths & English.
- NVQ Level 2 in Pharmaceutical Packaging would be advantageous.
- Clear and legible handwriting.
- A good standard of personal hygiene.
- Good practical aptitude with good hand and eye coordination along with good dexterity skills.
- A high level of attention to detail.
- Demonstrate a sound knowledge of cGMP principles.
Experience:
- Not less than 6 months experience in manufacturing in an allied industry.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
