Manager – API Compliance (CQA Role) | Ahmedabad
Position: Internal Auditor for API Compliance for multiple sites (CQA Role)
Job Profile:
- To review site responses to CAC audit for adequacy & supporting exhibits in ZyACTM.
- Tracking and review of regulatory/ Corporate commitments.
- To organize compliance meeting, follow up meetings / communication with site and CQ Leads to discuss unresolved observations or findings.
- To Present the progress in monthly reports for the site (include ZyACTM Response of audit reports) and participation in departmental meetings.
- To ensure SOP on Corporate Audit and Compliance” is followed effectively.
- To participate in need based corporate audits and compliance verification as per schedule.
- To support site for compliance during preparedness and follow up for updates compliance.
- To review regulatory/external SME and other external audit response/updates (as assigned by management) for adequacy and appropriateness.
- To participate in corporate policy preparation, review and implementation.
- To identify and escalate specific issue to management for compliance & support.
- To maintain all portals updated (ZyACTM, CQA Calendar, Regulatory commitment)
- Participation in development of new initiatives
- Preparation of monthly reports and participation in departmental meetings.
- Any other task assigned by reporting authority time to time for enhancement of compliance.
- System harmonization-Identification of need, escalation & Tracking for resolution.
- Travel to multiple sites as per requirement for audit purpose.
Candidate Requirements:
- Candidate Must have rich experience in API audit and compliance.
- Must have Excellent Communication, Auditing, Drafting and Leadership skills.
- Must be ready to travel on multiple sites for audit purpose.
Role:Quality Assurance - Other
Salary: 17-20 Lacs P.A.
Industry:Pharmaceutical & Life Sciences
Department:Quality Assurance
Role Category:Quality Assurance - Other
Employment Type:Full Time, Permanent
Education
PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
Company Profile
Zydus Lifesciences
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain. From formulations to active pharmaceutical ingredients and animal healthcare products to wellness products, Zydus has earned a reputation amongst Indian pharmaceutical companies for providing comprehensive and complete healthcare solutions.
One of the salient features of Zydus is its rich history and lineage. The origin of the company dates all the way back to the 1950s. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
In 1995, the group was restructured and thus was formed Cadila Healthcare under the aegis of the Zydus group. From a humble turnover Rs. 250 crores in 1995 the group witnessed a significant financial growth and registered a turnover of over Rs. 17,000 crores in FY-21.
Adhering to its brand promise of being dedicated to life in all its dimensions, Zydus continues to innovate with an unswerving focus to address the unmet healthcare needs. Simultaneously it rededicates itself to its mission of creating healthier, happier communities across the globe.
Contact Company:Zydus Lifesciences
Address:Survey No. 536, Scheme No.63, Zydus Corporate Park, S.G. Highway, Nr Vaishnodevi Circle, Khoraj,, Ahmedabad, Gujarat, 382481, AHMEDABAD, Gujarat, India
Reference Id:CQA CAC Role