Job Description

The essential and typically expected job duties for this position include but are not limited to the following:

• Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and following detailed documentation procedures to deliver the results to the QC Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.is preferred.
• Minimum of three (3) years' experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI or parentals preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

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