Assistant Manager, Quality Assurance

Apotex

10 - 15 years

35 - 40 Lacs

bengaluru

Posted:22 hours ago| Platform:

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Skills Required

accessories sap ipqa risk assessment pharmacy packaging gmp ms office licensing monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary

To implement efficient, quality processes at ARPL in alignment with global standards that comply with heath authority requirements.
IPQA activities, CCR initiation, Review, Approval, QA assessment, QA Responsible final closure of CCR in QMS Track wise.
SME for Swab/Rinse sampling, AQL, Cross contamination, MMaR S / MPaR S
MMaR S / MPaR s Review approval in live link.

Job Responsibilities

Ensure adherence to GMP regulatory requirements by one and all in the facility.
Planning Co-ordination of daily activities in Manufacturing and Packing areas.
Co-ordination ensuring timely execution of in-process activities for manufacturing packaging.
Preparation and Review of SOP Routine monitoring of all functional area to ensure adherence to the SOPs.
Co-ordination of change controls, SAP Notifications, Deviations and SME for QAIP related deviations. MMaR/MPaR block/unblock in SAP system.
Performing QA assessment for SOP S, Protocols, Master Manufacturing Records Master Packing records and other GMP records.
Initiation, Coordination for implementation of CAPA.
Quiz Review in GLMS.
In-process checks during manufacturing packing stage, performance Review of AQL, collection of samples as applicable and trending of AQL.
Sampling of SLED batches Hold time study sample, In-process samples/Finished product samples
Collection, storage and disposal of Reserve Sample.
Review of executed batch records log books. Co-ordination for Process validation cleaning validation execution.
To perform Swab/Rinse sampling for the cleaning verification validation programme, cleaning verification of sampling thief s accessories.
Perform, Review approval and co-ordination for in-house and external calibration.
Review approval of Master Manufacturing Records Master Packing records in live link.
Review and approval of Placebo and Submission batch documents.
Line clearance of various in process stage such as dispensing, granulation, compression coating, sampling, primary packing and secondary packing etc.
Preparation for internal, customers regulatory audits and making the compliance for the same.
Coordination for and performing gap assessment of Global Policies and Global SOPs.
Coordination for internal, customers regulatory audit compliance work.
Preparation, Review approval of Protocols and report.
To maintain the Quality Risk Assessment for cross-contamination which includes initiating risk review activities, as required.
Coordinate and manage Cross Contamination Control Program.
Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
Responsible and accountable for competently managing subordinates and to provide all required training, equipment, tools and follow procedures in accordance with applicable regulatory other pertinent requirements.
Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

Job Requirements

Education

Bachelor of Pharmacy/ Science or any equivalent degree.

Knowledge, Skills and Abilities:

Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
SME for IPQA activities Cross Contamination related activities.
Imparting training handling of team members (direct reports) with all compliance programs.
Maintaining cross contamination related activities, Preparation and review of SOP.
Live-link Track wise related to preparation and approval activities.
Handling of Deviation, active participants for CAPA, Market complaints, LIR, Qualification related activities.\

Experience:
- Minimum 10 Years of experience in GMP Regulated Pharmaceutical industry.

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