KEY ACCOUNTABILITIES
1.Quality Management/Continuous Improvement
Management and control of SOPs, Master documents, labels & other GMP impacted documents. Implementing necessary quality systems at the site including complaint Investigation, qualification and validation, change control, deviation and non-compliance management, documentation, supplier quality assurance etc. Out of specification & Out of trend investigation. Deviation Investigation. Incidence investigation. Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation. Validation & Qualification. Change control review & management. Preparing the Annual Product Review and Annual Quality Review. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling and non-standard batch size procedures as per applicable SOPs. Release/ rejection API & Intermediate. Conducting training program. Reviewing stability program. Review of Analytical method validation and qualification documents of Analytical instruments. Review of Equipment cleaning Records (ECRs). Issuance of all related GMP document. ComplianceEnsure adherence to Corporate Quality Directives, Local FDA regulations by
Knowing the requirements
Performing Gap analysis and making a compliance plan for closure of gaps
Audit trail review
Supporting Regulatory Affairs in related documentation.
Prepare for and attend to external / regulatory quality audits.
Review of calibration and preventive maintenance program.
Review of work orders.
GMP round in plant.
Review of Stability Analytical documents.
Review of Audit Trail.
Validation:
Review of validation plans, protocols and reports.
Review of qualification plans, protocols and reports.
Documentation Control:
Preparations of quality system SOPs.
Review of other departmental SOPs.
To ensure controlled distribution and archival of documents and records.
Control changes in master documents and records through change control procedure.
Assuring quality of products by
Ensuring compliance with applicable SOPs
Management of deviation/failure investigations
By controlling the changes made to facility / equipment / product / process and master documents and records by following change control procedure
Investigation of customer complaints
By ensuring implementation of corrective and preventive actions proposed in deviation/failure investigations, audit / inspection compliance, and customer complaint investigations.
Training :
To develop cGMP training modules and impart training.
Coordination
QC (Pharmaceuticals-Ankleshwar): For testing of water for microbiological attributes, environmental monitoring, stability program & local regulatory compliance.
HR&A for training activity
Purchase (Mumbai and Ankleshwar): For co-ordination of supplier QA activities
IS – Ensure IS compliance in coordination with IS experts.
Other
Coordinating with various agencies for making of the quality agreements.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To support supplier quality assurance activity as needed.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
To conduct Third parties audit as per company requirement.
To execute any special task allocated by Manager.
REQUIREMENTS
Education / Experience
M. Sc. Industrial Chemistry, having 8 to 10 years in API industry with related experience in the following fields: QA, Manufacturing & GMP.
Technical skills &
Competencies / Language
- Knowledge of GMP and regulatory requirements
- Good interpersonal, team working and conflict management skills
- To handle complex situations with regulatory compliance
- Understands global organization and related processes
- Excellent communication skills.
- Analytical technique
