Lab Compliance Lead

Job Purpose Accountable for the following activities Supports to the Laboratory functions to handle Investigations Deviation Management Specifications test methods method validations equipment qualifications internal audits and escalations if any Support to the Laboratory functions to meet compliance as per current requirements Internal audits GLP compliance Lab Investigations Lab Safety Risk management related to Quality department and Values expectation of the Organization Key Responsibilities To lead laboratory investigation through OOS incident investigations and deviation management To provide authorization approval of QC documents All related QC SOPs PQS for product and RMS PMSP for material preparation and review 100 CAP ATS compliance for Instruments To ensure adequate QC support to smooth implementation of new products at site Improve capability of analysts To escalate the stability failure OOT trend situation through LIC Management of CAP revisions gap assessments and change communication to respective SOP author To ensure compliance to EHS in QC areas of operation Reduction in the cGMP noncompliance coming from L1 L2 L3 L4 audits WHO audits Handling and maintenance of electronic systems e g Empower MERP VQD VQMS SLIMS etc Control on Lab Related SOPs Preparation and Review as per the schedule To ensure continuous improvement in laboratory working and to impart training to QC staff Drive improvements with respect to defect reduction in laboratory Prepare plan for L1 audit for QC with related documents and follow-up action of CAPA closure and change control Verify compliance to GMP Good Laboratory practice and Schedule L1of D C act To ensure the training compliance of QC personnel with the OJT Analyst Qualification My Learning modules and QMS training in time To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements Control and maintenance of documents including the quality systems as per the requirement of regulatory authorities which involves all raw data SOPs documentation exhibits Protocols training To ensure instrumental audit trail program reviewed and documented periodically To ensure compliance requirements and inspection readiness Support the department head to establish the activities assigned or identified as and when basis Ensure compliance to GPS principles LSW Gemba 3Z etc Reduce downtime of equipments and support for business continuity Ensure calibrations and qualification activities are tracked and maintain compliance To ensure safekeeping of controlled substances in the QC laboratory Knowledge Education Experience Required A Educational Background Minimum Level of Education - Minimum Level of Education Area of Specialisation - Science Pharmacy Why is this Level of Education Required - To understand co-ordinate of chemical testing activities at Nashik site Job-Related Experience Minimum Level of Job-Related Experience required - 5 years experience in Pharmaceutical Plant Other Job-Related Skills Background Attendance Management People Development Manpower Planning Area Management Site critical CIF delivery Level 2 audit completion Delivery of department budget Quarterly OT not exceeding 105 hrs and maintaining OT budget for month Ensuring no overdue QMS action in dept Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture These include Patient focus Transparency Respect Integrity along with Courage Accountability Development and Teamwork As GSK focuses on our values and expectations and a culture of innovation performance and trust the successful candidate will demonstrate the following capabilities Operating at pace and agile decision-making - using evidence and applying judgement to balance pace rigour and risk Committed to delivering high quality results overcoming challenges focusing on what matters execution Continuously looking for opportunities to learn build skills and share learning Sustaining energy and well-being Building strong relationships and collaboration honest and open conversations Budgeting and cost-consciousness Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people Important notice to Employment businesses Agencies GSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine