IPQA Officer ASolution Pharmaceuticals Pvt. Ltd
ASolution Pharmaceuticals Pvt. Ltd
Office Location
Full Time
Experience: 0 - 0 years required
Pay:
Salary Information not included
Type: Full Time
Location: Ambernath
Skills: cGMP, data integrity, Quality Assurance, Regulatory Guidelines, ICH Guidelines, Audits
About ASolution Pharmaceuticals Pvt. Ltd
Job Description
As an IPQA Officer in the Quality Assurance Department (QA), your primary responsibilities will include the following: - Drawing samples for Raw Materials (RM), Packaging Materials (PM), In-process, Intermediate, and Finished products. - Providing line clearance for dispensing activities, witnessing critical operations, and certifying critical operations. - Reviewing executed Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and Equipment Cleaning Records (ECR). - Conducting daily plant rounds to ensure compliance and reporting any non-compliance observed. - Monitoring product process-related activities and Stability Chamber functions. - Ensuring ALCOA principles for Data Integrity are followed. - Making QA observations on the shop floor and making online entries in the logbook. - Reviewing and approving Laboratory solution data for Raw Materials, In-process, Intermediates, and Finished products. - Performing equipment cleaning and temperature monitoring. - Carrying out other key functions of QA and any additional activities as designated by the Head of Department (HOD). Additionally, the ideal candidate should possess the following qualifications and skills: - Qualification: BSc/BPharm/MSc/Mpharm. - Experience: 0-2 years. - Familiarity with cGMP environment and current regulatory guidelines. - Knowledge of ICH guidelines and experience with audits by regulatory agencies such as WHO, US-FDA, EDQM/EU, etc. This is a full-time position with benefits including Provident Fund. The work schedule is during the day shift, and the work location is on-site.,