Assistant Manager, QualAssr-ARPL-AQAQ AR

Apotex

10 - 15 years

4 - 8 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

employee development compliance process efficiency pharma standard operating procedures investigation gmp licensing customer audits recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for effective review and approval of Change controls/ Laboratory investigation reports/ Deviations / Lab events/ Corrective action and preventive action (CAPA s).

Job Responsibilities

Review and approval of lab investigation reports (LIR), Deviations, Questionable results, Out of specification (OOS) and Out of trend (OOT) investigations.
Preparation and review of Standard operating procedures.
Review and approval of lab events and Temporary changes.
To review laboratory data with respect to investigations.
Co-ordinating with cross functional team for the closure of investigations in timely manner.
Responsible for review and approval in various stages of change controls like QA Acceptance, Change control assessment, QA summary, M-Doc approvals, action item verification & Final closure.
Co-ordination with regulatory department for regulatory submisssions/Post approval changes.
Review and approval of CAPA.
Review of LIR trend reports.
Responsible for approval of Specification/Certificate of analysis and method of analysis.
Support to regulatory and customer audits.
Identify system improvement opportunities for process efficiency.
Work both independent & as a part of intra/inter departmental teams to ensure that all work is completed in a timely manner to meet compliance.
Ensure to respond immediately on queries from cross functional teams.
Approval of reports wherever applicable.
Work as a member of a team to achieve all outcomes.
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.
Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion.
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.
Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
All other relevant duties as assigned.

Job Requirements

Education
- Minimum MSc/B. Pharm degree or any equivalent degree.

Experience
- Minium 10 years of experience in GMP regulated pharmaceutical industry.
Knowledge, Skills and Abilities

Good technical knowledge,possess problem solving and logical thinking capabilities.
Should have competent verbal & written communication skills.
Proper management skill and leading ability.
Good leadership quality and communication skill.

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