We are seeking a dynamic and experienced Production Documentation person in Active Pharmaceutical Ingredient (API) to support the development of the all GMP documentation activities .
You will be responsible for Initiation of change notification based on the requirement of the production for revising the SOPs, Batch production records (BPR), equipment cleaning records (ECR), Protocols (Process and Cleaning), Process flow, Process description, Reports and quality equivalence reports.
- Responsible for Timely updating the production SOPs, and associated forms.
- Responsible for Support or preparation/review of viable monitoring trends based on requirement
- Responsible for Initiation and closure of change notification and action items as per production requirements
- Responsible for Preparation for investigation reports/product failure/deviations and take necessary corrections, corrective actions and preventive actions by co coordinating with QA & other team like R&D/QC etc..
- Responsible for Preparation of process validation protocols/Batch execution protocol/trial protocol, BPRs and related documents.
- Responsible for Preparation of cleaning protocols, Equipment Cleaning Records & reports.
- Responsible for Preparing the Quality and Yield equivalence reports.
- Responsible for Attending to the cGMP / SOP / other training sessions as per requirement to update the knowledge and meet the compliance standards.
- Responsible for Actively participate in all the Internal & Regulatory Audits
- Responsible for Timely respond to all the observations from audits, QA Observations, and ensure to close all the points as per the time lines.
Educational qualification: B.Sc, M.Sc Chemistry
Minimum work experience: 2-4 years of experience in Pharma industry with documentation experience
Pay: ₹15,000.00 - ₹25,000.00 per month
Ability to commute/relocate:
- Dera Bassi, Punjab: Reliably commute or planning to relocate before starting work (Preferred)
Education:
Experience:
- Total: 2 years (Preferred)
Work Location: In person
