GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post: Site Audit Lead (Manager, Quality)
Job Description
The incumbent is accountable for:
- Implementation of effective internal auditing process across site and Quality oversight for the same.
- Effective implementation & management of the internal and external audit CAPAs through TrackWise
- Training and capability building for effective internal auditing process.
- Supporting Quality Governance, Audits, GMP compliance, Investigations, Safety related to Quality department.
Scope:
- Implementation of auditing standards as per GSK QMS and Regulatory requirements and to promote a Quality and compliance culture at the site.
Responsibilities:
- Documentation
- Maintenance and control of internal and external auditing documentation
- Preparation & review of all related SOPs and verification as per the GSK QMS, current pharmacopoeial and Regulatory requirements.
- Preparation, review and approval of the internal audit universe, schedules, plan and reports in timely manner as per the requirement.
Quality/ Compliance
- Guide the stakeholder on preparation of audit universe, schedules and timely review and revision of the same to comply QMS and regulatory requirements.
- Ensure compliance and inspection readiness at all the time
- Ensure safety and GxPs are followed at work place. Ensure correct and required SOPs are available.
- Ensure and co-ordinate for the timely planning, conduct, reporting of the internal audits including CAPA formulation and agreement.
- Timely gap analysis of the auditing processes against the QMS & regulatory requirements and plan for closure of the same in time bound manner.
- Identification and training of the personnel’s for conducting internal audits.
- Ensure internal auditing process is effective at site & delivering the expected results.
- Act as interface for timely finalization of the report and agreement on effective CAPAs for all the internal audits conducted on site.
- Conduct and drive periodic meetings of the Lead Auditors for improvement of the internal auditing process.
- Co-ordination with Global SMEs for improvement in internal auditing process and training across the site.
- Timely inputs for daily performance review meeting & Site Quality Council. Timely escalation of the issues.
Audit / checking activities
- Plan and conduct L1 & L2 audits as per the Audit schedule and follow-up action of CAPA for compliance
- Timely review and approval of the internal audit reports
Training
- To complete the QMS training in time and ensure the compliance with QMS in area of operation.
- To ensure that people at different levels are adequately trained for internal auditing capability and facing of the external audits.
- Conduct training session to uplift the internal auditing capability at site.
Support activities
- To support different systems implementation at site
- To support implementation of different projects for Quality department
- Co-ordination with cross functional team such as Mfg., QC,/QA, Engineering and Warehouse for internal audits.
For more info on next page...
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Candidate Profile
- B. Pharm / M. Pharm / M.Sc.
- 10 years of QA experience in Pharmaceutical Plant preferable which includes core auditing experience of at least 3 - 5 years
- Sound knowledge of quality standards prevailing in pharmaceutical industry
- Sound knowledge of SOPs and QMS
- Experience in quality system audits
- Knowledge of Regulatory, applicable EHS regulations
- Knowledge of the manufacturing sites, and the requirements of their external regulators
- Excellent communication skills and the ability to build relationships at all levels and across functions
- Should have Quality mindset
- Good knowledge of computer software (Word, Excel and Power Point)
- Competitive, energetic and results orientated.
- A natural team player and team builder
- Positive mindset with a can-do attitude in a dynamic growing environment
- Ability to prioritize work
- Good interpersonal, Excellent oral and written communication skills
- Systematic approach, People and Task oriented
- Flexible & adaptable to meet goals of organization
- Prepare accurate and precise technical document
Competencies:
- Excellent verbal and written communication skills
- Ability to problem-solve and use own initiative
- Flexible and adaptable while maintaining assertiveness.
- Able to think logically and act rationally when in a pressurized situation.
- High level of relationship building skills
Additional Information:
Experience: 3-5 years
Qualification: B. Pharm/ M. Pharm/ M.Sc
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
End Date: 20th August, 2015
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