PHARMA DOCUMENTALIST, Evening shift

1. JOB OBJECTIVES

Review documentation produced by the Omega 1 and Omega 2 production teams

2. PRIMARY FUNCTIONS

• Review manufacturing batch records for Omega 1 and Omega 2.
• Review autoclave, oven, parts washer, and VHP cycle records.
• Review production logs.
• Follow up on corrections with production supervisors and operators.
• Archive production documents (cycles and logs).
• Support production supervisors with any other documentation activities as required by operations.
• Draft, review, and approve Standard Operating Procedures (SOPs).
• Perform any other related duties deemed relevant to the position.

3. EXPERIENCE REQUIREMENT AND APTITUDES

• College diploma or any other relevant training.
• Minimum of 3 years of experience in a similar position, preferably in the sterile pharmaceutical industry.
• Minimum 3 years of experience in a similar position.
• Proficiency in Good Manufacturing Practices (GMP).
• Basic computer software knowledge.
• Leadership, initiative, resourcefulness, and autonomy.
• Strong organizational skills and results oriented.
• Analytical and synthesis skills with sound judgment.
• Interpersonal communication skills and problem-solving abilities.
• Team spirit and strong interpersonal skills.
• Ability to manage priorities and work under pressure with tight deadlines or frequent priority changes.