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Detailed Job Description
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- Perform line clearance and release activities according to established Standard Operating Procedures (SOPs).
- Conduct in-process quality checks on products during manufacturing and packaging, adhering to prescribed timelines.
- Accurately record test results in batch documentation to ensure complete traceability and compliance.
- Ensure the correct materials and components are used in production and packaging, following specifications outlined in BMR (Batch Manufacturing record), BPR (Batch packaging record), MPI (Master Packaging Instructions), MIV (Material Issue Voucher), or Dispensing Sheets.
- Maintain compliance strict adherence to Good Manufacturing Practices (cGMP) within the assigned area, ensuring proper documentation, verification of entries, and record integrity across batch records, logbooks, and labelling systems.
- Verify proper gowning attire, cleanliness, and adherence to SOPs, manufacturing instructions, and packaging instructions.
- Ensure environmental conditions (temperature, humidity, and differential pressure) meet the requirements for the product and the work area.
- Verify that in-process check equipment is properly calibrated and functions as intended.
- Assist in preparing the Annual Product Quality Review (APQR) for products as per established procedures.
- Participate in both internal and external audit programs.
- Handle tasks related to the Quality Management System (QMS) at the worksite.
- Participate/Conduct investigations into quality-related issues like deviations or complaints.
- Manage Corrective Action and Preventive Action (CAPA) processes within the Ampelogic system.
- Ensure that all (Manufacturing or packaging) activities in Manufacturing plants are performed in compliance with the requirements of the Regulation requirements of Good Manufacturing Practices (cGMP).
- Perform other duties as assigned by the QA Operations Team Leader/QA Manager.
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Core Competency
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- To be good in Process compliance
- Strong understanding and practice of 'cost consciousness'
- High on Accountability & Ownership
- Good in team building, Time & Task Management
- To be disciplined, Open for new learnings at the workplace
- follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
- Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
- Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiative
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Qualification/Functional Knowledge
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- Jr. Specialist required qualification:
- Bachelor’s degree in pharmacy, Science, or any related scientific field with 0-3 (or More) years of experience.
- Any other bachelor’s degree with 3+ years of experience in the pharmaceutical industry.
- High school with 5+ years of experience in the pharmaceutical industry.
- Good knowledge and command of cGMP.
- Good computer knowledge and knowledge of QMS system “Agile, Track wise, Amplelogic”
- To be proficient in English.
- Quality and Business decision maker& Risk assessment knowledge
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