- Determine whether quality activities and related results comply with cGMP requirements
- To perform review of executed manufacturing and packaging batch record to ensure that the batch has been manufactured / packaged as per the requirement and or instructions of respective manufacturing and/or packaging batch record.
- To engage cross-functionally as required to manage completion of required batch record corrections by interacting with responsible parties and counseling personnel on proper cGMP documentation practices.
- To ensure that all the batch related deviation, repair and maintenance form are closed prior to releasing of the batch as a part of review process.
- To compile and perform data entry for the required critical data determined for each product in order to support the Annual Product Quality Review (APQR) reports preparation as related to executed records for manufacturing and packaging records.
- To support as needed document control holding and record handing over activity such as to maintain the manufacturing and packaging batch record until submitted for final archival.
- To engage, coordinate and communicate as required with concerned department for outsourced contract manufacturing/packaging activity for record reviews and corrections as required to ensure accuracy and completeness and CGMP compliance.
- To assist in QA review of the new master documents such as master manufacturing records, master packaging batch record, characterization and validation protocol’s, IQ-OQ and PQ’s etc.
- Participate on need from QA perspective to monitor IQ-OQ-and PQ, Process validation, process characterization, cleaning validation or verification and time limit validation monitoring.
- To assist in review of existing SOP so as to ensure its meets the expectation of 21 CFR and is always current.
- Assist and support on need all the QA related functions required to be performed and carried out as per established company standard and procedures and assure that manufacturing / production is according to cGMP regulation.
- Perform final batch release through SAP for interstate commerce
- All other job-related duties to be performed as required to meet the company goals.
Specialized Skills and Knowledge:
- Knowledge about various Oral Solid Dosage manufacturing activity (dispensing, blending, Granulation, compression, coating, Packaging etc.
- Knowledge of In-process testing like – Hardness testing, Thickness testing, Disintegration testing, Friability testing etc including the knowledge of related instruments.
- Basic knowledge of working on computers – MS Office.
List the three (3) most important competencies required:
- Analytical and review skills.
- Problem identification and solving skills.
- Knowledge of good documentation practices.
- Minimum Associate degree with Chemistry as a major subject alternatively minimum 3 years of experience in working as a floor QA / review for a pharmaceutical company
- While performing the duties of this job, the employee is regularly required to sit and work with computers. The employee is frequently required to walk in and out of QC section. The employee must occasionally lift and or move up to 25 pounds.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs
Employee signature below constitutes employee’s understanding of the requirements, essential functions and duties of the position.