JOB TITLE Assistant Manager-I, Quality Control, ChemistryREQUIREMENTSEducation / Experience M.Sc. Analytical/Organic Chemistry/Inorganic Chemistry Min. 5 to 8 years’ Experience in a Quality Control/Analytical laboratory in a cGMP/ISO environment.Technical skills &Competencies / Language · Technical competence · Leadership skills · Analytical ability · Planning ability · Communication skills · Problem solving · Team BuildingBehavioural Competencies(LEAD and others) · Leveraging group values ‘Accountability, Authenticity, Collaboration, Courage and Trust’ during day to day operationsJOB PURPOSEGeneric To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to Quality operations and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics.KEY ACCOUNTABILITIES1. Analysis and approval1.1. Sampling, analysis and ascertaining quality of raw materials, packaging material, intermediates, In-process samples and API for Chemistry Ankleshwar.1.2. Testing of the method validation samples and process validation samples and cleaning validation.1.3. Perform analysis and documentation of API finished product stability study as per stability study protocol.1.4. Coordinating with Production, Stores and QA for Approval / Rejection of raw materials/finished product.1.5. Validation and verification of analytical procedures as per requirement.1.6. Reporting OOS / OOT results and deviations.1.7. Maintaining retained samples as per standard procedure.1.8. Assisting in investigation of customer complaint.1.9. Testing of new samples (Vendor approval)\1.10. Reference standards/working standard analysis and qualification1.11. Training of subordinates1.12. Give required suggestion for corrective actions and to plan effective preventive actions for the upgradation of the quality system.1.13. To ensure proper maintenance of the stability samples and their management.1.14. Disposal of waste according to the approved procedures.1.15. Continual reduction in the waste generation and effluent management.1.16. Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities.2. Documentation2.1. Pharmacopoeia review2.2. Generation, managing and archiving Documents including raw data, reports, COA etc as per requirements.2.3. Preparation and implementation of the SOPs in the laboratories system. 2.4. Specification preparation and implementing for API raw material and API finished product according to requirement.2.5. Maintaining routine data & reference and working standard management in LIMS2.6. Providing technical support in compiling Annual Product Review.2.7. Analytical method development when required.2.8. Executing on line documentation2.9. Statutory documentation and management2.10. QMS activities3. Laboratory Management3.1. Qualification and Validation of instruments/equipment’s3.2. Appropriate training and guidance to the subordinates.3.3. Safety in the laboratory.3.4. Regular housekeeping and upkeep of the work area.3.5. Maintaining adequate inventory of chemicals and reference standards.3.6. Adapting relevant technologies and systems in Quality control.3.7. Laboratory equipment calibration and their maintenance.3.8. Generate up gradation plans as need basis.3.9. Any other activity assigned by the In charge, Quality control4. Quality, HSE and Compliance4.1. Adhere to current GMP guidelines4.2. Following ALCOA+++ practices during documentation and related activities 4.3. Timely investigation and closure of OOS/OOT/OOC & laboratory incidences 4.4. Preparation of trends of process water, OOS/OOT/OOC & laboratory incidences4.5. Compliance to local and international HSE norms4.6. Regulatory compliance4.7. ISO 14000 related activities4.8. Regular Pharmacopoeia and regulatory requirement review for compliance 4.9. To participate in any regulatory/Customer inspection takes place at the site 4.10. Training of self and subordinates on quality and HSE systems5. Team member5.1. Member of validation team.5.2. Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities.6. Other projects6.1. Supporting new projects (analytical method development (need base), validation, verification)6.2. Laboratory compliance by reviewing documents for completeness6.3. Preventive maintenance, Instrument calibration6.4. New Instrument Qualification6.5. Coordination with OEMs/Service providers for timely services
