Senior Manager Quality Control
Location
Dhanaura | India
Job description
Who We Are
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
The Opportunity Will be leading entire QC Section as Section in charge hence should be well verse with Internal and external Audits, Compliance. Should have worked as SME (Subject Matter Expert) for compliance, investigation, Change Control, CAPA, SOP & QC related activities in plant. Should be having experience into USFDA, GMPs, TTA & UGMP. Should be well versed with regulatory knowledge. Should be strong into instrumentation qualification and calibration techniques and should know functioning of micro, HPLC, wet chemistry. Should have experience in Track wise, Mpower, LIMS TMO.
How You'll Spend Your Day - Application of a quality system in the lab, in accordance with up-to-date requirements of the regulatory authorities.
- Independent reviewer for laboratory investigations and reporting the status further.
- Qualification and maintenance of laboratory instruments in QC at TIG. Ensure smooth working and optimum usage of instruments.
- New SOP's generation and periodic revision of existing SOP's and timely closure of their change controls. Ensure the adequacy of SOP's w.r.t. regulatory requirements.
- Generation of new instruments user requirement specifications, risk assessment, Functional specification, and validation protocols/ reports for all validation activities in Quality Control department of TIG.
- Monitoring of stability studies with respect of ICH Q1 & conducting the validation with respect to ICH Q2.
- Preparation, review & approval of specification of RM/FP/STP & SOP.
- Implementing quality system with respect to regulatory ICH & CGMP requirement.
- Signing on approved column in data books, laboratory control card and signing on the COA of final material and signing on hard copies as well as approval in LIMS.
- Professional / regulatory training of QC Lab Employees.
- Accountable for the budget, performance and results of a medium-sized team or multiple small teams
- Exercises full management authority, including performance reviews, pay decisions, recruitment, discipline, termination and other personnel actions.
- Addresses issues with impact beyond own team based on knowledge of related disciplines.
- Manages professional employees and/or supervisors or supervises large, complex technical or business support or production operations team(s).
- Is accountable for the performance and results of a team within own discipline or function.
- Adapts departmental plans and priorities to address resource and operational challenges.
- Decisions are guided by policies, procedures and business plan; receives guidance from senior manager.
- Provides technical guidance to employees, colleagues and/or customers.
Your Experience And Qualifications - 15 + years' experience into Pharma API with 5+ years audit Experience.
- MSC in Biotechnology, MSC chemistry, MSc – Instrumentation or Pharmacology
Reports To Assoc Dir Plant/Site Qlty Control
Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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