GSK - Site Manager (8-15 yrs)
Job description :
Site Name: India - Maharashtra - Aurangabad, India - Maharashtra - Worli Mumbai
Education: B Pharma / BSc / MSc with 8 to 15 years of experience
- Has exposure to quality / production / packing / operations excellence/ EHS
- Has experience of working in Sites
- Lead and co-ordinate site tasks aimed to ensure the production of high-quality and compliant, competitively priced products. Influence site leadership team to deliver forecasted/ planned supplies covering across all areas - safety, quality, service, cost in line with GSK values.
- Manage Site level business performance which includes CTP, Quality, OOS, Wastes, Compliance, EHS and cost dimensions.
- Ensure audit actions/ CAPA Observations are implemented on time with required resources.
- Have Shop floor Gemba (Quality, EHS, Efficiency, Wastage, Productivity) on regular intervals and make observations
- To ensure Implementation of GSK QMS requirements at contract sites and to ensure that product is getting manufactured at the site as per cGMP requirements.
- To provide support in the area of regulatory compliance at contract sites and to ensure no disruption of supply & no regulatory punitive action, ensure availability and use of current PPI, SPS, Artworks ASL, RMS, MFR and FPS at contract manufacturing sites.To ensure all time GMP audit readiness. Follow up with sites for compliance of audit. Ensure CAPAs are adequate and are tracked to completion ensuring zero CAPA overdue.
- To ensure all time ESA audit readiness Follow up with sites for compliance of audit. Ensure CAPAs are adequate and are tracked to completion ensuring zero CAPA extensions
- Perform QMS gap analysis and follow-up for effective QMS implementation
- Monitor wastages/Write off - destruction process and take accountability as per GSK norms
- Approve change control, Out of Specs and deviation raised by Site after consulting the OQ Lead.
- To ensure timely release of finished products by resolution of all issues.
- Ensure that there is well defined stability program in place and is maintained by site for all GSK products. Ensure stability study is conducted for all products at assigned sites as per schedule. Review of stability data on regular basis and identify any significant changes / stability failures and ensure relevant actions. Develop people on site to ensure that site has proper capability in line with site performance.
- Accountable for continuous improvement projects and savings at the site. To draw support from center as and when needed.
- To assist in smooth Product Transfers and meeting on FSTM
- Track material analysis status - Raw / FG / Packing, WIP, Not started and completed
- Track labor compliance with focus on payment of minimum wage act, Child labor act, Payment of wage act, labor legislation.
- Prepare and own Risk charter for Site.
- Provide oversight for product investigations/RCA.
- Carry out APQR/PPR review.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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